Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor (MADUTER)
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| ClinicalTrials.gov Identifier: NCT03744364 |
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Recruitment Status :
Completed
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
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Sponsor:
Hospital Miguel Servet
Information provided by (Responsible Party):
Jose Manuel Campillos Maza, Hospital Miguel Servet
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Brief Summary:
Purpose:
To compare the efficacy and safety of low-dose protocol of vaginal misoprostol and vaginal dinoprostone insert for induction of labor in women with post-term pregnancies.
Methods:
The investigators designed a prospective, randomized, open-labeled, blinded for the end-point evaluators trial including women of at least 41 weeks of gestational age with uncomplicated singleton pregnancies and Bishop score lower than 6. Participants were randomized into dinoprostone or misoprostol groups in a 1:1 ratio. Baseline maternal data and perinatal outcomes were recorded for statistical analysis. Successful vaginal delivery within 24 hours was the primary outcome variable.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Induced Labor Cervical Ripening Obstetric Labor Pregnancy | Drug: Misoprostol 25 mcg Drug: Dinoprostone 10mg | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 198 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Low-dose Vaginal Misoprostol Versus Vaginal Dinoprostone Insert for Induction of Labor Beyond 41st Week: a Randomized Trial |
| Actual Study Start Date : | June 1, 2014 |
| Actual Primary Completion Date : | October 20, 2017 |
| Actual Study Completion Date : | November 1, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Misoprostol
Group of women allocated to misoprostol induction.
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Drug: Misoprostol 25 mcg
To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
Other Name: Misoprostol induction |
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Active Comparator: Dinoprostone
Group of women allocated to dinoprostone induction.
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Drug: Dinoprostone 10mg
To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
Other Name: Dinoprostone induction |
Primary Outcome Measures :
- Successful vaginal delivery within 24 hours [ Time Frame: 24 hours since induction was started ]Percentage of women that achieve a vaginal delivery within 24 hours since induction process started
Secondary Outcome Measures :
- Successful cervical ripening within 24 hours [ Time Frame: 24 hours since induction was started ]Percentage of women that achieve Bishop score > 6 within 24 hours since induction process started
- Interval time from induction to delivery [ Time Frame: Hours passed between induction of labor until delivery within 72 hours ]Time passed since induction of labor started until delivery
- Need for a second induction [ Time Frame: Assessed 24 hours since induction of labor was started ]Percentage of women that require to use a second method for induction of labor after 24 hours of having started induction of labor
- Vaginal delivery rate [ Time Frame: Since labor induction had started until delivery had ocurred within 72 hours ]Percentage of women that achieve vaginal delivery
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Pregnant women |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Singleton uncomplicated pregnancy
- Nulliparity
- Live fetus
- 286 days of gestational age or above
- Abscence of contraindication for vaginal delivery
- Bishop score lower than 6
Exclusion Criteria:
- Multiple pregnancy
- Multiparity
- Stillbirth
- Oligohydramnios
- Suspected fetal distress
- Severe asthma
- Intolerance/allergy to prostaglandins
- Contraindication for vaginal birth
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jose Manuel Campillos Maza, Head of Unit of Maternal-Fetal Medicine, Hospital Miguel Servet |
| ClinicalTrials.gov Identifier: | NCT03744364 |
| Other Study ID Numbers: |
JMC-PGE-2014-01 |
| First Posted: | November 16, 2018 Key Record Dates |
| Last Update Posted: | November 16, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Jose Manuel Campillos Maza, Hospital Miguel Servet:
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Dinoprostone Misoprostol |
Additional relevant MeSH terms:
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Misoprostol Dinoprostone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |