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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
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring IUFD, POSTTERM, ROM

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Female

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

First Posted
February 6, 2007
Last Updated
May 31, 2007
Sponsor
Hormozgan University of Medical Sciences
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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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