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

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

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

Study Overview

• Status: Completed
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Drug: Placebo; Drug: Misoprostol; Drug: Propranolol

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • El Sharquia
    • Zagazig, El Sharquia, Egypt, 055
      • Ahmed mohamed fathy ismail

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Placebo; placebo; Drug: Misoprostol; Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction delivery interval	The time from starting induction to the delivery	procedure delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	Vaginal delivery or cesarian section	delivery

Collaborators and Investigators

• Sponsor: Ahmed mohamed fathy ismail
• Collaborators: 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 record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ACTUAL): September 13, 2020
• Study Completion (ACTUAL): September 15, 2020

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (ACTUAL): September 1, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Propranolol; Misoprostol
• Other Study ID Numbers: Ahmed mohamed fathy ismail

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study results will be available
• IPD Sharing Time Frame: September 2020
• IPD Sharing Access Criteria: Researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No