Induced Vaginal DeliveryNCT06560515
Dinoprostone Versus Vaginal Misoprostol for Induction of Labour
A study testing Vaginal Dinoprostone in people with Induced Vaginal Delivery, run by University of Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Vaginal Dinoprostone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women at 40 weeks or beyond
- singleton pregnancy
- Bishop score 4 or more
- fetus in a cephalic presentation
- Adequate fetal biophysical profile
Who cannot join
- Any signs of labour (Prelabor rupture of membranes)
- Grand Multiparous women (parity of 4 or more)
- IUFD
- fetal weight > 4 kg
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.
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.
- Conditions
- Induced Vaginal Delivery
- Being tested
- Vaginal Dinoprostone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal DinoprostoneDrug
induction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Dinoprostone | Experimental | received 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart. Receives: Drug: Vaginal Dinoprostone |
| Vaginal Misoprostol | Active comparator | received 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart. Receives: Drug: Vaginal Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sucess of induction
percentage of women with a successful vaginal delivery
Measured: number of women who delivered vaginally after induction
Induction to delivery time
time lapse from receiving first dose of induction till delivery of the fetus
Measured: time from start of induction till delivery of the fetus
Secondary outcomes (2)
Postpartum hemorrhage
quantification of amount of postpartum bleeding
Measured: after delivery of the placenta
neonatal outcomes
Apgar Score at 1 and 5 minutes
Measured: at 1 and 5 minutes of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Aug 2022
- Primary completion31 Jul 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Sheikhelarab Elsedeek Ibrahim Omran, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560515
- Sponsor's protocol ID
- 0107227
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Dinoprostone Versus Vaginal Misoprostol for Induction of Labour in Post-dated Pregnancy; a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06560515
- Acronym / sponsor ID
- 0107227
- Conditions
- Induced Vaginal Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Dinoprostone | Experimental | Drug: Vaginal Dinoprostonereceived 3 mg vaginal Dinoprostone of maximum 2 doses 6 hours apart. |
| Vaginal Misoprostol | Active comparator | Drug: Vaginal Dinoprostonereceived 50μg of vaginal misoprostol of maximum 2 doses 6 hours apart. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- pregnant women at 40 weeks or beyond
- singleton pregnancy
- Bishop score 4 or more
- fetus in a cephalic presentation
- Adequate fetal biophysical profile
Key exclusion criteria (5 listed)
- Any signs of labour (Prelabor rupture of membranes)
- Grand Multiparous women (parity of 4 or more)
- IUFD
- fetal weight > 4 kg
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Dinoprostoneinduction of labour in women with postdate pregnancy with vaginal dinoprostone vs. vaginal misoprostol | Drug | Vaginal Dinoprostone, Vaginal Misoprostol |
Primary outcome
Sucess of induction
Time frame: number of women who delivered vaginally after induction
percentage of women with a successful vaginal delivery
Induction to delivery time
Time frame: time from start of induction till delivery of the fetus
time lapse from receiving first dose of induction till delivery of the fetus
2 secondary outcomes
Postpartum hemorrhage
Time frame: after delivery of the placenta
neonatal outcomes
Time frame: at 1 and 5 minutes of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Induced Vaginal Delivery
Not yet recruiting
Outcome of Concurrent Versus Sequential Method of Induction of Labour in Term Pregnancy
Induced; Birth
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Ripening Approaches for Prompt Induction and Delivery - Sequential Versus Concurrent Dilapan-S and Misoprostol to Achieve Vaginal Delivery (RAPID-DS)
Nulliparous Women Who Scheduled for Labor Induction, Pregnancy
Not yet recruiting
RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
Perineal Trauma, Postpartum Pain
Active, not recruiting
Comparison of Vaginal PGE2 (Dinoprostone) and Vaginal Misoprostol for Induction of Labour in Primigravid Term Pregnancy
Labor, Induced, Term Pregnancy
Recruiting
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Premature Rupture of Fetal Membranes, Labor, Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal Dinoprostone in people with Induced Vaginal Delivery, run by University of Alexandria at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sucess of induction (time frame: number of women who delivered vaginally after induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.