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Clinical Trial Results:
The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.

Summary
EudraCT number	2019-004697-25
Trial protocol	IE
Global end of trial date	28 Jul 2023

Results information
Results version number	v1(current)
This version publication date	10 Apr 2026
First version publication date	10 Apr 2026
Other versions
Summary report(s)	HOME IND Results Lancet

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

V609May2023

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Royal College of Surgeons in Ireland

Sponsor organisation address

111 St Stephens Green, Dublin, Ireland,

Public contact

Mandy Jackson, Royal College of Surgeons Ireland, +353 18093863, mandyjackson@rcsi.com

Scientific contact

Mandy Jackson, Royal College of Surgeons Ireland, +353 18093863, mandyjackson@rcsi.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 Jul 2023

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Jul 2023

Global end of trial reached?

Yes

Global end of trial date

28 Jul 2023

Was the trial ended prematurely?

Main objective of the trial

To demonstrate non-inferiority in the efficacy of Dilapan-S® (12 hours or 24 hours insertion) to Propess for outpatient induction of labour at 39 weeks’ gestation in otherwise uncomplicated, normal risk* nulliparous women. the following conditions should be met to consider a pregnancy to be normal risk Singleton pregnancy Cephalic presentation Term gestation (37-39 weeks gestational age) Maternal pre-pregnancy body mass index < 35kg/m2 Maternal age of ≥ 18 and < 40 years No evidence of the following conditions: Pre-pregnancy diabetes Gestational diabetes Pre-pregnancy hypertension Cervical cerclage in situ Premature rupture of membranes Congenital fetal anomalies

Protection of trial subjects

All subjects were consented using a Sponsor approved informed consent SOP and an ethically approved patient information leaflet and consent form. A Data Safety Monitoring Board was convened to assess the study safety at intervals defined in the charter. All serious adverse events were captured from Visit 2 until 6 weeks post partum and each SAE that occurred in the trial was reviewed by the Data Safety Monitoring Board

Background therapy

N/A

Evidence for comparator

N/A

Actual start date of recruitment

01 Jul 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Ireland: 327

Worldwide total number of subjects

327

EEA total number of subjects

327

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

327

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Identification of potential subjects was from the antenatal clinic lists. Potential participants who wished to enquire about the study through advertising were able to contact the investigator. The expected number of participants available for screening over 30 months was approximately 7500, with a sample size of 327 to be recruited.

Screening details

Participants were identified from the antenatal clinic lists at the maternity site (at <39+0 gestational age). Eligible women who consented to trial participation had their details entered onto the Patient Enrolment Log which identifed the patients by a unique identification number.

Period 1 title

Randomisation

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

N/A open label trial

Are arms mutually exclusive

Yes

Propess

Arm description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours

Arm type

Experimental

Investigational medicinal product name

Propess (Cervidil)

Investigational medicinal product code

Other name

Dinoprostone 10mg vaginal insert

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Vaginal use

Dosage and administration details

10mg vaginal delivery system over 24 hours

Dilapan 12

Arm description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Arm type

Experimental

Investigational medicinal product name

Dilapan-S

Investigational medicinal product code

Other name

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Intracervical use

Dosage and administration details

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Dilapan 24

Arm description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Arm type

Experimental

Investigational medicinal product name

Dilapan-S

Investigational medicinal product code

Other name

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Intracervical use

Dosage and administration details

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours

Number of subjects in period 1	Propess	Dilapan 12	Dilapan 24
Started	110	107	110
Completed	87	88	96
Not completed	23	19	14
Consent withdrawn by subject	5	2	5
unknown	-	2	-
spontaneous onset of labour	12	12	7
developed exclusion criteria	6	3	2

Period 2 title

Post Randomisation Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

N/A

Are arms mutually exclusive

Yes

Propess

Arm description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours.

Arm type

Experimental

Investigational medicinal product name

Propess (Cervidil)

Investigational medicinal product code

Other name

Dinoprostone 10mg vaginal insert

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Vaginal use

Dosage and administration details

10mg vaginal delivery system over 24 hours

Dilapan 12

Arm description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Arm type

Experimental

Investigational medicinal product name

Dilapan-S

Investigational medicinal product code

Other name

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Intracervical use

Dosage and administration details

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Dilapan 24

Arm description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Arm type

Experimental

Investigational medicinal product name

Dilapan-S

Investigational medicinal product code

Other name

Pharmaceutical forms

Vaginal delivery system

Routes of administration

Intracervical use

Dosage and administration details

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours

Number of subjects in period 2	Propess	Dilapan 12	Dilapan 24
Started	87	88	96
Completed	87	88	96

Baseline characteristics

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Reporting group title

Propess

Reporting group description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours

Reporting group title

Dilapan 12

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Reporting group title

Dilapan 24

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Reporting group values	Propess	Dilapan 12	Dilapan 24	Total
Number of subjects	110	107	110	327
Age categorical
Units: Subjects
In utero				0
Preterm newborn infants (gestational age < 37 wks)				0
Newborns (0-27 days)				0
Infants and toddlers (28 days-23 months)				0
Children (2-11 years)				0
Adolescents (12-17 years)				0
Adults (18-64 years)				0
From 65-84 years				0
85 years and over				0
Age continuous
Units: years
arithmetic mean (standard deviation)	27.3 ( 4.8 )	27.4 ( 5.3 )	27.1 ( 5.2 )	-
Gender categorical
Units: Subjects
Female	110	107	110	327
Male	0	0	0	0
Body Mass Index
Units: kilogram(s)/square metre
arithmetic mean (standard deviation)	( )	( )	( )	-

Subject analysis set title

Per protocol analysis

Subject analysis set type

Per protocol

Subject analysis set description

The primary analysis population for non-inferiority will be the per-protocol population. The analyses performed was in the per-protocol population, supported by an intention-to-treat analysis.

Subject analysis sets values	Per protocol analysis
Number of subjects	271
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age continuous
Units: years
arithmetic mean (standard deviation)	27.2 ( 5.1 )
Gender categorical
Units: Subjects
Female	271
Male	0
Body Mass Index
Units: kilogram(s)/square metre
arithmetic mean (standard deviation)	25.7 ( 4 )

End points

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Reporting group title

Propess

Reporting group description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours

Reporting group title

Dilapan 12

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Reporting group title

Dilapan 24

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Reporting group title

Propess

Reporting group description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours.

Reporting group title

Dilapan 12

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Reporting group title

Dilapan 24

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Subject analysis set title

Per protocol analysis

Subject analysis set type

Per protocol

Subject analysis set description

The primary analysis population for non-inferiority will be the per-protocol population. The analyses performed was in the per-protocol population, supported by an intention-to-treat analysis.

Primary: Vaginal Delivery Rate

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End point title

Vaginal Delivery Rate

End point description

End point type

Primary

End point timeframe

Measured at Visit 4 (delivery visit)

End point values	Propess	Dilapan 12	Dilapan 24	Per protocol analysis
Number of subjects analysed	87	88	96	271
Units: vaginal deliveries	16	28	48	194

Statistical analysis primary endpoint

Statistical analysis description

Median [inter-quartile range] or mean (standard deviation), in the absence of skewness, were used to summarize outcome data. SAS Version 9.2 was used to analyse the data

Comparison groups

Propess v Dilapan 12 v Dilapan 24 v Per protocol analysis

Number of subjects included in analysis

542

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[1]

P-value

= 0.026 ^[2]

Method

Wald Test

Confidence interval

Notes
[1] - A non-inferiority margin of 10% in vaginal delivery rates was considered to be clinically meaningful, consistent with other trials comparing induction methods in the inpatient setting. Given that this was a non-inferiority trial, the per-protocol analysis was considered the primary population for analysis, although an ITT analysis was also completed. Median [inter-quartile range] or mean (standard deviation), in the absence of skewness, were used to summarize outcome data. SAS Version 9.2 used
[2] - A non-inferiority p-value, using a Wald test, was calculated to aid interpretation

Adverse events

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Timeframe for reporting adverse events

All Adverse Events (AEs) occurring during the trial were recorded on the CRF, except for those events that met the definition of a non-reportable event. All AEs were recorded from Visit 2 until 6 weeks post partum.

Adverse event reporting additional description

There were overall 20 SAEs that occurred in this trial and within certain SAEs, there were multiple events to be MedDRA coded within a case. Therefore the below represents a total of 20 SAE cases only.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Propess

Reporting group description

Patients randomised to receive Propess administered vaginally at a standard dosing protocol, i.e. 1 device containing 10mg dinoprostone over 24 hours.

Reporting group title

Dilapan 12

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 12 hours

Reporting group title

Dilapan 24

Reporting group description

Patients randomised to receive Dilapan-S® at a standard dosing protocol, i.e. the required number of rods intra-cervically over 24 hours.

Serious adverse events	Propess	Dilapan 12	Dilapan 24
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 88 (6.82%)	5 / 87 (5.75%)	9 / 96 (9.38%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Vascular disorders
Subgaleal haematoma
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Deep vein thrombosis
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subgaleal haemorrhage
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Cooling therapy
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis prophylaxis
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
subjects affected / exposed	1 / 88 (1.14%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 88 (1.14%)	2 / 87 (2.30%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Vulvovaginal burning sensation
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient tachypnoea of the newborn
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Coagulation test abnormal
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ultrasound head abnormal
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood gases abnormal
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood lactic acid increased
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haemoglobin decreased
subjects affected / exposed	1 / 88 (1.14%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Injury to brachial plexus due to birth trauma
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iatrogenic injury
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Perineal injury
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital pneumonia
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Phrenic nerve paralysis
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Encephalopathy
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Jaundice
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Jaundice neonatal
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Pain in extremity
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Lower respiratory tract infection
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inclusion conjunctivitis neonatal
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mastitis
subjects affected / exposed	2 / 88 (2.27%)	0 / 87 (0.00%)	2 / 96 (2.08%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subdiaphragmatic abscess
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Acidosis
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Feeding disorder
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Propess	Dilapan 12	Dilapan 24
Total subjects affected by non serious adverse events
subjects affected / exposed	54 / 88 (61.36%)	51 / 87 (58.62%)	53 / 96 (55.21%)
Investigations
Neutrophilia
Additional description: Raised WCC or Neutrophilia
subjects affected / exposed	3 / 88 (3.41%)	3 / 87 (3.45%)	3 / 96 (3.13%)
occurrences all number	3	3	3
Surgical and medical procedures
Retained placenta operation
subjects affected / exposed	1 / 88 (1.14%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences all number	1	1	0
Cardiac disorders
Bradycardia
Additional description: Maternal bradycardia
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	1 / 96 (1.04%)
occurrences all number	1	0	1
Tachycardia
Additional description: Maternal tachycardia >100bpm
subjects affected / exposed	11 / 88 (12.50%)	7 / 87 (8.05%)	13 / 96 (13.54%)
occurrences all number	11	7	13
Nonreassuring foetal heart rate pattern
Additional description: Non reassuring fetal testing
subjects affected / exposed	30 / 88 (34.09%)	32 / 87 (36.78%)	29 / 96 (30.21%)
occurrences all number	30	32	29
Nervous system disorders
Headache
Additional description: Post dural headache
subjects affected / exposed	2 / 88 (2.27%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences all number	2	1	1
Pregnancy, puerperium and perinatal conditions
Shoulder dystocia
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	1 / 96 (1.04%)
occurrences all number	0	1	1
Uterine hyperstimulation
subjects affected / exposed	3 / 88 (3.41%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences all number	3	0	0
Blood and lymphatic system disorders
Anaemia
Additional description: Anaemia <80g/L
subjects affected / exposed	1 / 88 (1.14%)	2 / 87 (2.30%)	1 / 96 (1.04%)
occurrences all number	1	2	1
Thrombocytopenia
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	2 / 96 (2.08%)
occurrences all number	0	1	2
Respiratory, thoracic and mediastinal disorders
Tachypnoea
subjects affected / exposed	1 / 88 (1.14%)	2 / 87 (2.30%)	0 / 96 (0.00%)
occurrences all number	1	2	0
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	0 / 88 (0.00%)	1 / 87 (1.15%)	0 / 96 (0.00%)
occurrences all number	0	1	0
Infections and infestations
COVID-19
subjects affected / exposed	1 / 88 (1.14%)	0 / 87 (0.00%)	0 / 96 (0.00%)
occurrences all number	1	0	0
Urinary tract infection
subjects affected / exposed	0 / 88 (0.00%)	0 / 87 (0.00%)	2 / 96 (2.08%)
occurrences all number	0	0	2

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Were there any global substantial amendments to the protocol? Yes

11 Jan 2021

Version 2 protocol dated 11-Jan-2021: details of amendment: "Removal of the following non-reportable Aes from protocol: 1. Failure to progress in labour 2. Non-reassuring fetal heart rate tracings during labour 3. Obstetric need for cesarean delivery, forceps-assisted delivery, vacuum-assisted delivery, or episiotomy "

19 Feb 2021

Clarity added around timeframe in exclusion criterion Addition of non-reportable concomitant medications Footnote added to schedule of assessments to allow partner of trial subjects to receive phonecalls

01 Oct 2021

Version 4 protocol dated 01-Oct-2021 had the following changes: "Additional site and contact details added Recruitment numbers updated to reflect second site Visit 5 amended to allow for phone or chart review follow up Visit 3 timeframe amended Footnotes added to schedule of assessments for clarity on procedures Addition of non reportable AE of ""infections unrelated to labour and delivery"""

28 Nov 2022

Version 5 protocol amended: -Removal of National Maternity Hospital as a site and corresponding National Maternity Hospital PI details -Changed from 24 to 30 months -Clarity provided in the inclusion criteria around what are considered relevant medical issues that would be considered when assessing eligibility. Wording added also to outline that this is assessed on a case by case basis. -Clarity provided in the exclusion criteria that known maternal health problems that would directly affect the risk status of the woman are exclusionary. Wording added also to outline that this is assessed on a case by case basis. -updated risks section; Updated based on revisions to Section 4.8 of the Propess SmPC. Based on new Propess SmPC dated 17-Nov-2021 and Typo corrected “tocolytics” -Statistical changes made by statistician -Wording amended to allow for scenario where Propess or Dilapan falls out -section added regarding new born admissions that are to be captured as adverse events. Non reportable adverse events for the new born were added. -events were added to the non-reportable adverse events in pregnancy

09 May 2023

Protocol V6 amended with wording regarding number of subjects planned revised to read “recruitment will continue until 285 subjects can be analysed”

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/36814336

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Clinical trials

Clinical Trial Results:
The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.

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Trial information

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Subject disposition

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Baseline characteristics

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End points

Primary: Vaginal Delivery Rate

Primary: Vaginal Delivery Rate

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Substantial protocol amendments (globally)

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Clinical trials

Clinical Trial Results: The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Vaginal Delivery Rate

Primary: Vaginal Delivery Rate

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.