Vaginal Misoprostol Before IUD Insertion in Women With Cesarean Scar
Condition: Contraceptive Device; Complications
Study type: Interventional
Phase: Phase 4

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      The outer sheath of the insert was withdrawn a short distance to release the arms of the T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.
    

Intervention name(s): Misoprostol; Intrauterine contraceptive device IUCD
Intervention type(s): Drug; Device
Intervention description(s): 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion; 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 intervention name(s): cytotec; TCu-380A®,Pregna International Ltd, India
Intervention MeSH terms: Misoprostol; Contraceptive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other