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OpenTrials
Completed

NCT Number: NCT04533841

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ahmed mohamed fathy ismail

Zagazig, El Sharquia, 055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol

Drug

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

Placebo

Drug

placebo

Propranolol

Drug

Propranolol

Primary outcomes

  1. Induction delivery interval

    Time frame: procedure delivery

    The time from starting induction to the delivery

Secondary outcomes

  1. Mode of delivery

    Time frame: delivery

    Vaginal delivery or cesarian section

Sponsors and collaborators

Lead sponsor

Ahmed mohamed fathy ismail

Other

Collaborators

  • Ain Shams University

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2020
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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