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Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar

NCT03081442 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-06

No results posted yet for this study

Summary

Groups of study:

120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.

Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.

Methodology:

All patients were subjected to the following:

(i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .

(vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology .

A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.

The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection.

The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.

The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .

The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os.

Conditions

  • Contraceptive Device; Complications

Interventions

DRUG

Misoprostol

600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion

DEVICE

Intrauterine contraceptive device IUCD

bimanual examination. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution. The Next step was to sound The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange. The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged · Kasr Alainy medical school

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081442 on ClinicalTrials.gov