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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-10

Study Completion Date

2025-10-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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early induction of labour for PROM

The patients assigned with this arm when presented with PROM were inducted immidiately for labour and no observation was done for 24 hours for spontaneous induction of labour

Group Type EXPERIMENTAL

0.5mg PGE2 gel

Intervention Type DRUG

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)

Late induction of Labour in PROM

The patients assigned with this arm were observed for 24 hours for any spontanous induction of labour and then only proceeded with manual induction.

Group Type ACTIVE_COMPARATOR

0.5mg PGE2 gel

Intervention Type DRUG

The patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina.

Interventions

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0.5mg 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)

Intervention Type DRUG

0.5mg PGE2 gel

The patients assigned with this intervention will be observed for 24 hours following which induction will be done using 0.5mg PGE2 gel in posterior fornix of vagina.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No