ClinicalTrials.gg
CompletedNCT06560515Updated Aug 19, 2024

Dinoprostone Versus Vaginal Misoprostol for Induction of Labour

An interventional study of Vaginal Dinoprostone in Induced Vaginal Delivery, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Aug 2022, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
370
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

This randomized controlled study was carried out on 370 pregnant women with gestational age ≥ 40 weeks of different ages and parities at El-Shatby Maternity University Hospital after approval of ethical committee of Alexandria Faculty of Medicine. After assessment for eligibility \& enrollment in the study, women were randomly assigned into one of the two study groups, Group (I) received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart and Group (II) received 50 μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

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Conditions studied

  • Induced Vaginal Delivery
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In context

Lead sponsor

University of Alexandria is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women at 40 weeks or beyond
  • singleton pregnancy
  • Bishop score 4 or more
  • fetus in a cephalic presentation
  • Adequate fetal biophysical profile

Exclusion criteria

Exclusion Criteria:

  • Any signs of labour (Prelabor rupture of membranes)
  • Grand Multiparous women (parity of 4 or more)
  • IUFD
  • fetal weight > 4 kg
  • BMI > 35
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
370 participants (actual)

Study arms

  • Experimental
    Vaginal Dinoprostone

    received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart.

    Drug: Vaginal Dinoprostone

  • Active comparator
    Vaginal Misoprostol

    received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart.

    Drug: Vaginal Dinoprostone

Interventions

  • induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol

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What researchers measure

Primary outcomes

  1. Sucess of induction

    percentage of women with a successful vaginal delivery

    Time frame: number of women who delivered vaginally after induction

  2. Induction to delivery time

    time lapse from receiving first dose of induction till delivery of the fetus

    Time frame: time from start of induction till delivery of the fetus

Secondary outcomes

  1. Postpartum hemorrhage

    quantification of amount of postpartum bleeding

    Time frame: after delivery of the placenta

  2. neonatal outcomes

    Apgar Score at 1 and 5 minutes

    Time frame: at 1 and 5 minutes of delivery

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Study locations

1 site
  • ElShatby University Maternal Hospital
    Alexandria, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Jul 2023, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2024
First posted
Aug 19, 2024
StartActual
Aug 1, 2022
Primary completionActual
Jul 31, 2023
CompletionActual
Oct 31, 2023
Last update
Aug 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06560515
Lead sponsor
University of Alexandria
Responsible party
Mervat Sheikhelarab Elsedeek Ibrahim Omran (Professor of Obstetrics and Gynaecology, University of Alexandria) — Principal investigator
First posted
Aug 19, 2024
Start date
Aug 1, 2022
Primary completion
Jul 31, 2023
Completion
Oct 31, 2023
Last update
Aug 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dinoprostone

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