Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section
SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial
1 other identifier
interventional
124
1 country
1
Brief Summary
The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 18, 2015
March 1, 2015
8 months
May 15, 2014
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain.
During the procedure
Secondary Outcomes (2)
Difficulty of Procedure
During the procedure
Complications
During the procedure and the following 24 hours.
Study Arms (2)
Misoprostol
EXPERIMENTALWomen will receive two sub lingual tablets each containing 200 micro gram misoprostol (Misotac), receiving a total dose of 400 micro grams. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
Placebo
PLACEBO COMPARATORWomen will receive two sub lingual placebo tablets which will be similar in size, color, odor and shape to the misoprostol tablets. Two hour later, Cu T 380A IUD (PREGNA) will be inserted.
Interventions
Eligibility Criteria
You may qualify if:
- Normal size uterus.
- Willing to participate.
- Candidate for IUD insertion.
- Delivered only by cesarean section.
- Last delivery is more than 40 days before participating in the study.
You may not qualify if:
- Previous vaginal delivery
- Signs of genital infection.
- Menopause.
- Body mass index (BMI) \> 35 kg/m2.
- Contraindication to misoprostol.
- Copper allergy.
- Positive pregnancy test.
- Had a prior attempt for IUD insertion.
- Uterine anomalies.
- Uterine fibroid.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Maternity Hospital
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed S. Sweed, MD
Ain Shams University
- STUDY DIRECTOR
Hassan A. Bayoumy, Professor
Ain Shams University
- PRINCIPAL INVESTIGATOR
Mohamed Y. Mohamed, M.B., B.Ch.
Assiut University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University.
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 19, 2014
Study Start
May 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 18, 2015
Record last verified: 2015-03