E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Maternal infection in the first six weeks after operative vaginal delivery. |
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E.1.1.1 | Medical condition in easily understood language |
Maternal infection in the first six weeks after operative vaginal delivery. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Principal research question: Is a single dose of antibiotic following operative vaginal delivery clinically effective for preventing confirmed or presumed maternal infection?
Principal research objective: To compare the incidence of confirmed or suspected maternal infection in the first six weeks after operative vaginal delivery amongst women who have received an antibiotic versus those who received placebo.
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E.2.2 | Secondary objectives of the trial |
Secondary research objective: To investigate the effect of the intervention on various other short-term maternal outcomes, including severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital / GP visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breast feeding, wound breakdown and occurrence of anaphylaxis. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women aged 16 years or above, willing and able to give informed consent. - Women who have had an operative vaginal delivery at 36+0 weeks or greater gestation.
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E.4 | Principal exclusion criteria |
Women may not enter the trial if ANY of the following apply: - Clinical indication for ongoing antibiotic administration post-delivery e.g. due to confirmed antenatal infection, 3rd or 4th degree tears. Note that receiving antenatal or postnatal antibiotics e.g. for maternal Group B Streptococcal carriage or prolonged rupture of membranes, is not a reason for exclusion if there is no indication for ongoing antibiotic prescription post-delivery. - Known allergy to penicillin, as documented in hospital notes.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome measure: Confirmed or suspected maternal infection within 6 weeks of delivery, as defined by one of: - A new prescription of antibiotics - Confirmed systemic infection on culture - Endometritis as defined by the US Centers for Disease Control and Prevention (Centers for Disease Control and Prevention 2013)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Confirmed or suspected maternal infection within 6 weeks of delivery, as defined by one of: • A new prescription of antibiotics • Confirmed systemic infection on culture • Endometritis as defined by the US Centers for Disease Control and Prevention (Centers for Disease Control and Prevention 2013)
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E.5.2 | Secondary end point(s) |
- Systemic sepsis: defined according to modified SIRS criteria (Waterstone, Bewley et al. 2001, Acosta, Kurinczuk et al. 2013). - Perineal wound infection: defined according to the Public Health England Surveillance definition of surgical site infection (SSI) (Public Health England (Health Protection Agency) 2013). - Surgical Site infection (perineal): Identified using the items included in the Public health England “surgical wound healing post discharge questionnaire” (Public Health England (Health Protection Agency) 2013). - Perineal pain/use of pain relief/dyspareunia/ability to sit comfortably to feed the baby/need for additional perineal care/breast feeding: Identified using standard questions developed for the HOOP study (McCandlish, Bowler et al. 1998) and the PREVIEW study (Ishmail, personal communication). - Maternal general health: As elicited by the EQ-5D-5L (Herdman, Gudex et al. 2011). Hospital bed stay/Hospital and GP visits/Wound breakdown/antibiotic side effects: Identified through specific questions included in the maternal questionnaire, to include medications prescribed, critical care admission, hospital inpatient admissions, outpatient visits, midwife and practice nurse visits, and social care visits. - Hospital admissions and diagnoses at one-year post delivery identified from linked Hospital Episode Statistics data.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Telephone interview at 6 weeks post-delivery.
- A postal or online questionnaire (as preferred by each woman) at six weeks post-delivery, following initial telephone interview.
- Clinical data collection from the woman’s medical records or hospital laboratory at six weeks post-delivery if the initial telephone interview indicates that the woman has been admitted, or had samples sent for culture.
- Data from linked information contained within Hospital Episode Statistics (for hospital admissions and diagnoses at one-year post delivery identified from linked Hospital Episode Statistics data only)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Person administering trial drug will not be blinded. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is the date when the database is locked. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |