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Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

A

Ain Shams University

Status

Unknown

Conditions

Normal Vaginal Delivery

Treatments

Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT03863392
test123

Details and patient eligibility

About

Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods.

To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Full description

Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.

A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).

II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Enrollment

100 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Primigravida or Primipara
  • Pregnancy between 36 and 42 weeks of gestation.
  • A live singleton fetus in cephalic presentation.
  • No history of uterine surgery.
  • Clinically adequate pelvis.
  • Modified Bishop's score <5.
  • Reactive Non stress test (NST) .

Exclusion criteria

  • •Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).

    • Any antenatal medical complications.
    • A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
    • Non-reactive NST.
    • Patient's refusal to give consent

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

oral
Experimental group
Description:
patients undergoing induction of labour using misoprostol oral solution
Treatment:
Drug: Misoprostol
vaginal
Experimental group
Description:
patients undergoing induction of labour using vaginal misoprostol
Treatment:
Drug: Misoprostol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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