Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
Primary Purpose
Preeclampsia, Fetal Death, Fetal Membranes, Premature Rupture
Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
misoprostol
dinoprostone
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia focused on measuring IUFD, POSTTERM, ROM
Eligibility Criteria
Inclusion Criteria:
- Term pregnancy
- Singleton
- Vertex
- Bishop score below 6
Exclusion Criteria:
- History of drug reaction
- Medical disease
- IUGR
- Oligohydramnios
- Vaginal bleeding
- Fetal anomaly
- Uterine scar
Sites / Locations
- Shariaty Maternity Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00432588
First Posted
February 6, 2007
Last Updated
May 31, 2007
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00432588
Brief Title
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Fetal Death, Fetal Membranes, Premature Rupture
Keywords
IUFD, POSTTERM, ROM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
misoprostol
Intervention Type
Drug
Intervention Name(s)
dinoprostone
10. Eligibility
Sex
Female
Eligibility Criteria
Inclusion Criteria:
Term pregnancy
Singleton
Vertex
Bishop score below 6
Exclusion Criteria:
History of drug reaction
Medical disease
IUGR
Oligohydramnios
Vaginal bleeding
Fetal anomaly
Uterine scar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitra Ahmad Soltani
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minoo Rajaee Lari, Perinatologist - Obs and Gyn
Organizational Affiliation
Department of Obs and Gyn - HUMS
Official's Role
Study Chair
Facility Information:
Facility Name
Shariaty Maternity Hospital
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitra Ahmad Soltani, MD
Phone
0098 021 22301004
Email
m_a_sol@yahoo.com
12. IPD Sharing Statement
Links:
URL
http://www.rcog.org.uk
Description
Related Info
Learn more about this trial
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
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