Investigation into the effectiveness of progesterone prevention of preterm labour in women who became pregnant by in vitro fertilisation (IVF)/ intra-cytoplasmic sperm injection (ICSI)
Completed
- Conditions
- Prevention of preterm labour after IVF/ICSIPregnancy and ChildbirthPreterm labour
- Registration Number
- ISRCTN06959967
- Lead Sponsor
- Marcyrl (Egypt)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 302
Inclusion Criteria
Healthy women who became pregnant after IVF/ICSI (singleton or twin). Randomisation will be carried out, on average, during the 20th week of gestation.
Exclusion Criteria
1. Rupture of membranes
2. Smokers
3. Major known foetal anomalies
4. Uterine anomalies
5. Cervical cerclage
6. Treatment during this pregnancy with progesterone after 12 weeks' gestation (use up to 10 weeks' gestation is permitted)
7. Contraindications to tocolysis, including foetal distress, chorioamnionitis, preeclampsia, hemodynamic instability
8. Patients treated with oral beta adrenergics for asthma
9. Age <18 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delivery <37 weeks' gestation.
- Secondary Outcome Measures
Name Time Method 1. Neonatal outcome<br>2. Incidence of prematurity<br>3. Admission to neonatal intensive care unit (ICU)<br>4. Complication of prematurity