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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533841
• Other study ID #: Ahmed mohamed fathy ismail
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: August 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 15, 2020
• Est. primary completion date: September 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Drug:
• Misoprostol
Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol
• Placebo
placebo
• Propranolol
Propranolol

Locations

Country	Name	City	State
Egypt	Ahmed mohamed fathy ismail	Zagazig	El Sharquia

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed mohamed fathy ismail	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction delivery interval	The time from starting induction to the delivery	procedure delivery
Secondary	Mode of delivery	Vaginal delivery or cesarian section	delivery