Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar

NCT03081442 | Completed Phase 4 DMC

• 1 other identifier: 159
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .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

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain scores were measured by Visual analogue scale (VAS) consists of 10 cm horizontal straight line with 2 ends At 0 end there was no pain and at 10 there was a severe pain

  At time of insertion

Secondary Outcomes (2)

• Difficulty of insertion of IUD in both groups

  At time of insertion

• side effects

  from time of administration till insertion

Study Arms (2)

Misoprostol group

ACTIVE COMPARATOR

Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.

Drug: Misoprostol; Device: Intrauterine contraceptive device IUCD

placebo group

PLACEBO COMPARATOR

Sixty women received the placebo vaginally six hours before IUD insertion. Placebo is the same in size, color and shape to misoprostol.

Device: Intrauterine contraceptive device IUCD

Interventions

Misoprostol DRUG

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

Also known as: cytotec

Misoprostol group

Intrauterine contraceptive device IUCD DEVICE

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 .

Also known as: TCu-380A®,Pregna International Ltd, India

Misoprostol group; placebo group

Eligibility Criteria

• Age: 19 Years - 44 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with previous cesarean section and with no previous vaginal delivery attending outpatient clinic for IUD insertion

You may not qualify if:

• contraindications for misoprostol use (pregnancy and prostaglandin allergy).
• contraindications for IUD use (gynecologic malignancy, pelvic inflammatory disease and unexplained vaginal bleeding).
• previous vaginal delivery. And (4) medical disorders as diabetes, hypertension and bleeding tendency .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

MeSH Terms

Interventions

Misoprostol; Intrauterine Devices

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Study Officials

• Ahmed Maged

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: April 11, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)