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

NCT04533841 | Completed Phase 2 DMC

• 1 other identifier: Ahmed mohamed fathy ismail
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• Induction delivery interval

  The time from starting induction to the delivery

  procedure delivery

Secondary Outcomes (1)

• Mode of delivery

  delivery

Study Arms (2)

Misoprostol + propranolol

ACTIVE COMPARATOR

Patient who receive misoprostol then after 30minutes receive propranolol

Drug: Misoprostol; Drug: Propranolol

Misoprostol + placebo

PLACEBO COMPARATOR

Pt who will receive misoprostol then after 30minutes receive placebo

Drug: Misoprostol; Drug: Placebo

Interventions

Misoprostol DRUG

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

Misoprostol + placebo; Misoprostol + propranolol

Placebo DRUG

placebo

Misoprostol + placebo

Propranolol DRUG

Propranolol

Misoprostol + propranolol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female full term pregnancy primigravida
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed mohamed fathy ismail: lead
• Ain Shams University: collaborator

Study Sites (1)

Ahmed mohamed fathy ismail

Zagazig, El Sharquia, 055, Egypt

Location

Related Publications (1)

• Abdel Hamid AS, El Zeneiny H, Fathy A, Nawara M. A pilot study to compare propranolol and misoprostol versus misoprostol and placebo for induction of labor in primigravidae; a randomized, single-blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2023 Apr 4;23(1):226. doi: 10.1186/s12884-023-05537-1.

  PMID: 37016326 DERIVED

MeSH Terms

Interventions

Misoprostol; Propranolol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ahmed S Abd El hamid, A.professor

  Ain Shams University

  STUDY DIRECTOR

• Hazem A Hassan elzeneiny, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded research
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Model Details: Clinical trial

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 1, 2020
• Study Start: February 1, 2020
• Primary Completion: September 13, 2020
• Study Completion: September 15, 2020
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: September 2020
• Access Criteria: Researchers

Locations

EG (1)