Prevention of preterm birth in twin pregnancies - Randomised trial of progesterone versus placebo”

Phase 3

Completed

Conditions: Preterm birth
Pregnancy and Childbirth

Registration Number: ISRCTN66445401

Lead Sponsor: Foundation for Health Education & Research (Fundación para la Formación e Investigación Sanitaria)

Brief Summary: 2021 results in https://pubmed.ncbi.nlm.nih.gov/32598909/ (added 26/01/2021)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1194

Inclusion Criteria

1. Aged 18 years or over
2. Dichorionic diamniotic (DCDA) or monochorionic diamniotic (MCDA) twin pregnancies;
3. Live fetuses at 11-13 weeks of gestation;
4. English or Spanish speaking (otherwise interpreters will be used)

Exclusion Criteria

1. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment, including nuchal translucency thickness >3.5 mm
2. In MCDA twin pregnancies there are early signs of twin-to-twin transfusion syndrome (TTTS) (20% discordance in crown-rump length [CRL] and/or nuchal translucency [NT])
3. Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness
4. Hypersensitivity to progesterone
5. Concurrent participation in another drug trial or at any time within the previous 28 days
6. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of spontaneous delivery before 34 weeks (238 days) of gestation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The incidence of spontaneous preterm birth <37 weeks (259 days) of gestation<br> 2. Birth weight below the 3rd, 5th and 10th centile<br> 3. Rate of stillbirth or neonatal death due to any cause<br> 4. Major adverse outcomes before discharge from the hospital (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotising entercolitis)<br> 5. Need for neonatal special care (admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion)<br>