Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar

Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial

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The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .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

Study Overview

• Status: Completed
• Conditions: Contraceptive Device; Complications
• Intervention / Treatment: Drug: Misoprostol; Device: Intrauterine contraceptive device IUCD

Detailed Description

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.

Methods of randomization:

To insure that everyone had an equal chance of participation, randomization was guided by table of random numbers using computer generated system(SPSS: windous version8) (SPSS Inc., Chicago, USA) double blinding technique was used thus; the investigator and the patient didn't know the group to which the patient was allocated.

Methodology:

All patients were subjected to the following:

(i) Complete history taking:

• Full history taking.
• Obstetric history.
• Menstrual history.
• Medical history. Data were collected in a special form for each patient. (ii) Proper counseling: Proper counseling of each patient about different types of IUDs, the advantage and side effects of each type, explanation of the menstrual pattern changes, assuring the patient that these changes are very common and that it will disappear after a period of time after insertion.

(iii) Consent: Informed consent is taken from each patients . (iv) Examination:

1. General examination.
2. Abdominal examination.

3. Pelvic examination to exclude pelvic pathology .

   (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo ( stugeron®, Mina Pharm. under licence Janssen Pharmaceutica, Egypt ) 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 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 .

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

   Post insertion instructions:

   Palpation of strings should be performed monthly by the patient to verify continuing presence of the IUD after each menstrual flow. Caution the patient that the first 2 menses are typically heavier.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol group; Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.	Drug: Misoprostol; 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion; Other Names: cytotec; 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 .; Other Names: TCu-380A®,Pregna International Ltd, India
Placebo Comparator: placebo group; 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; 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 .; Other Names: TCu-380A®,Pregna International Ltd, India

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty of insertion of IUD in both groups	Difficulty of IUD insertion was measured by a 10-point scale, on which 0 represented an extremely easy, and 10 an extremely difficult insertion	At time of insertion
side effects	abdominal cramps, headache, nausea, diarrhea and fever	from time of administration till insertion

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Maged, Kasr Alainy Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 1, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Contraceptive Agents; Misoprostol
• Other Study ID Numbers: 159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No