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)

The effect of rectal progesterone on the latency period as well as maternal and prenatal outcome in PPROM between 24-33+6 Weeks

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN65694106

Enrollment

216

Registered

2014-07-18

Start date

2016-03-01

Completion date

Unknown

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm premature rupture of membrane (PPROM) Pregnancy and Childbirth Preterm premature rupture of membrane (PPROM)

Interventions

Rectal progesterone (Cyclogest) and placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To determine the effect of rectal progesterone on the Latency Period in PPROM. The outcomes will be measured using three forms: recruitment form, follow-up form, and research end form. These forms where designed by the authors using focused group discussion. These forms will be completed by the treating physicians. The recruitment and the research end forms will be completed only once, when the patient agrees to participate in the study and when the patient is discharged from our care, respectively. The follow-up form will be filled twice weekly.	—

Measure

Time frame

To determine the effect of rectal progesterone on the Latency Period in PPROM. The outcomes will be measured using three forms: recruitment form, follow-up form, and research end form. These forms where designed by the authors using focused group discussion. These forms will be completed by the treating physicians. The recruitment and the research end forms will be completed only once, when the patient agrees to participate in the study and when the patient is discharged from our care, respectively. The follow-up form will be filled twice weekly.

—

Secondary

Measure	Time frame
To find out the effect of rectal progesterone on maternal outcomes of: 1. Hospitalization 2. ICU admission 3. Chorioamnionitis 4. Post-partum haemorrhage 5. Post-partum pyrexia 6. Endometritis 7. Maternal death Prenatal outcome of: 1. Birth weight 2. Apgar score 3. Neonatal morbidity 4. Neonatal intensive care unit (NICU) stay 5. Intrauterine fetal death (IUFD) 6. Neonatal death in PPROM	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026