Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas

Phase 2

Completed

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Drug: Misoprostol; Drug: Propranolol; Drug: Placebo

• Registration Number: NCT04533841
• Lead Sponsor: Ahmed mohamed fathy ismail

Brief Summary

To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas

Detailed Description

Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to.

- Study procedure:

1. Written informed consent will be obtained from all participants prior to the study.

2. Full history taking.

3. General examination.

Patients will be subjected to the following:

* Patients attending labour room for induction of labour will be divided into two groups.

* Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses.

* In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg

* In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets.

* After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-01
• Primary Completion: 2020-09-13
• Study Completion: 2020-09-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• • Primigravidas.

  • Full term patients with ultrasound confirmed dates.
  • Singleton.
  • Cephalic presentation.
  • Fetal heart rate between 120 to 160 beats per minute.

Exclusion Criteria

• • Any history of previous surgery on the uterus.

  • Patients in active labour, with ruptured membranes.
  • Fetal distress.
  • Macrosomia or polyhydramnios
  • Hypersensitivity to prostaglandins.
  • Asthmatic patient .
  • liver or kidney impairment .
  • known cardiac patient with abnormal ECG.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol + propranolol	Propranolol	Patient who receive misoprostol then after 30minutes receive propranolol
Misoprostol + placebo	Placebo	Pt who will receive misoprostol then after 30minutes receive placebo
Misoprostol + propranolol	Misoprostol	Patient who receive misoprostol then after 30minutes receive propranolol
Misoprostol + placebo	Misoprostol	Pt who will receive misoprostol then after 30minutes receive placebo

Primary Outcome Measures

Name	Time	Method
Induction delivery interval	procedure delivery	The time from starting induction to the delivery

Secondary Outcome Measures

Name	Time	Method
Mode of delivery	delivery	Vaginal delivery or cesarian section

Trial Locations

Locations (1)

Ahmed mohamed fathy ismail; 🇪🇬 Zagazig, El Sharquia, Egypt