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Early V/S Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes

A Comparative Study on Early Versus Delayed Induction of Labour in Patients With Prelabour Rupture of Membranes at Term

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261332
Acronym
PROM
Enrollment
88
Registered
2025-12-03
Start date
2025-05-10
Completion date
2025-10-10
Last updated
2025-12-03

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

Conditions

Induction of Labor, Labor (Obstetrics)--Complications, Prelabor Rupture of Membranes

Keywords

prelabor rupture of membranes, complicated labor, early Versus delayed labor induction

Brief summary

To compare the effects of early V/s delayed induction of labour and its outcomes in patients presenting with PROM without labour.

Detailed description

This is a comparative study where the patient who presented with PROM were assigned 2 groups of intervention . One had early induction of labour and other had induction of labour after 24 hours of observation. Both groups were compared for the average time of labour till delivery of the fetus and the frequency of spontaneous vaginal delivery was also calculated for each group.

Interventions

DRUG0.5mg PGE2 gel

In this interventional group patients presenting with PROM will be immediately induced by 0.5mg PGE2 gel. If bishop score will not improve after 6 hours, then application of PGE2 gel will be repeated (maximum 2 doses)

Sponsors

Laiba Qamar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

1. singleton pregnancy with cephalic presentation 2. gestational age between 37-41 weeks as calculated by last menstrual period date or early dating ultrasoumd 3. Spontaeous PROM as confirmed by history and sterile speculum examination 4. modified bishop score \<6 5. no detectable uterine contractions on admission 6. clear liqour and duration of PROM \<6 hours at admission

Exclusion criteria

1. meconium stained liqour 2. patients with features of chorioamnionitis (fever , tachycardia, abdominal tendernessor foul smeeling vaginal discharge 3. maternal medical diseaseincluding prompt delivery or C section like severe preeeclampsia, renal or cardiac disease 4. presence of contraindications to labour such as placenta previa , Vasa previa,previous uterine surgery (e.g myomectomy ) that increases the risk of uterine rupture , previous C section 5. history of antepartum hemorrhage 6. Moderate to severe IUGR as diagnosed on ultrasound and doppler studies

Design outcomes

Primary

MeasureTime frameDescription
Duration of labour24 hoursthe duration of labour was assesed after each method of induction when patients presented with PROM

Secondary

MeasureTime frameDescription
Frequency of Normal Vaginal Delivery24 hoursFrequency of having a vaginal delivery was calculated in each interventional group

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026