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

Sponsor

Ahmed mohamed fathy ismail (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04533841

Collaborator

Ain Shams University (Other)

128

Enrollment

Location

Arms

11.5

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Induction of Labor Affected Fetus / Newborn	Drug: Misoprostol Drug: Placebo Drug: Propranolol	Phase 2

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:

Written informed consent will be obtained from all participants prior to the study.
Full history taking.
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 Design

Study Type:

Interventional

Actual Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical trialClinical trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double blinded research

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Sep 13, 2020

Anticipated Study Completion Date :

Jan 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol + propranolol Patient who receive misoprostol then after 30minutes receive propranolol	Drug: Misoprostol Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol Drug: Propranolol Propranolol
Placebo Comparator: Misoprostol + placebo Pt who will receive misoprostol then after 30minutes receive placebo	Drug: Misoprostol Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol Drug: Placebo placebo

Arm

Intervention/Treatment

Active Comparator: Misoprostol + propranolol

Patient who receive misoprostol then after 30minutes receive propranolol

Drug: Misoprostol

Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol

Drug: Propranolol

Propranolol

Placebo Comparator: Misoprostol + placebo

Pt who will receive misoprostol then after 30minutes receive placebo

Drug: Misoprostol

Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol

Drug: Placebo

placebo

Outcome Measures

Primary Outcome Measures

Induction delivery interval [procedure delivery]
The time from starting induction to the delivery

Secondary Outcome Measures

Mode of delivery [delivery]
Vaginal delivery or cesarian section

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed mohamed fathy ismail	Zagazig	El Sharquia	Egypt	055

Sponsors and Collaborators

Ahmed mohamed fathy ismail
Ain Shams University

Investigators

Study Director: Ahmed S Abd El hamid, A.professor, Ain Shams University
Study Director: Hazem A Hassan elzeneiny, Professor, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed mohamed fathy ismail, Director, Ain Shams University

ClinicalTrials.gov Identifier:

NCT04533841

Other Study ID Numbers:

Ahmed mohamed fathy ismail

First Posted:

Sep 1, 2020

Last Update Posted:

Jan 14, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propranolol

Misoprostol

Study Results

No Results Posted as of Jan 14, 2021