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

Laiba Qamar

Status: Completed

Conditions: Labor (Obstetrics)--Complications; Prelabor Rupture of Membranes; Induction of Labor

Treatments: Drug: 0.5mg PGE2 gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07261332

#PLROM225#

Details and patient eligibility

About

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

Full 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.

Enrollment: 88 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

88 participants in 2 patient groups

early induction of labour for PROM

Experimental group

Description:

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

Treatment:

Drug: 0.5mg PGE2 gel

Drug: 0.5mg PGE2 gel

Late induction of Labour in PROM

Active Comparator group

Description:

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

Treatment:

Drug: 0.5mg PGE2 gel

Drug: 0.5mg PGE2 gel