The effect of rectal progesterone on labor, and the prevention of preterm delivery, as well as minimizing the maternal and prenatal complications due to Preterm Premature Rupture Of Membrane (PPROM)

Not Applicable

Completed

• Conditions: Preterm premature rupture of membrane (PPROM); Pregnancy and Childbirth

• Registration Number: ISRCTN65694106
• Lead Sponsor: mm Al-Qura University

Brief Summary

2015 protocol in http://dx.doi.org/10.18203/2349-3259.ijct20151239 (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-18
• Study Completion: 2016-03-01
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

1. 18-45 years old
2. Singleton live fetus
3. 24 to 33 weeks
4. Confirmed PPROM

Exclusion Criteria

All fetal & maternal conditions that could affect fetal and maternal outcomes

Maternal:
1. Maternal fever
2. Antepartum haemorrhage
3. Chorioamnionitis
4. Preterm labour (PTL)
5. Pre-existing diabetes
6. Preeclampsia
7. Cervical cerclage
8. Severe medical diseases
9. Allergy to progestin or placebo
10. Medical condition that might adversely interact with progesterone
11. Medical condition treated with systemic steroid
12. PPROM >48 hours prior presentation
13. Unsure gestational age

Fetal:
1. Fetal chromosomal abnormality
2. Fetal anomaly
3. Non reassuring surveillance (BPP < 4 / 10)
4. IUGR

Study & Design

• Study Type: Interventional
• Study Design: Not specified