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

A

Ahmed mohamed fathy ismail

Status and phase

Completed
Phase 2

Conditions

Induction of Labor Affected Fetus / Newborn

Treatments

Drug: Propranolol
Drug: Placebo
Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT04533841
Ahmed mohamed fathy ismail

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

128 participants in 2 patient groups, including a placebo group

Misoprostol + propranolol
Active Comparator group
Description:
Patient who receive misoprostol then after 30minutes receive propranolol
Treatment:
Drug: Misoprostol
Drug: Propranolol
Misoprostol + placebo
Placebo Comparator group
Description:
Pt who will receive misoprostol then after 30minutes receive placebo
Treatment:
Drug: Misoprostol
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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