Clinical trial NCT03081442: Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar
Official title: Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraceptive Device; Complications
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .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

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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Pain score
timeFrame: At time of insertion
Secondary outcomes:
measure: Difficulty of insertion of IUD in both groups
timeFrame: At time of insertion
measure: side effects
timeFrame: from time of administration till insertion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: