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Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial
Sponsor study identifier
interventional
120
1 country
1
Study Start
April 11, 2017
Actual (reported)Primary Completion
November 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)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 The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2017
Actual (reported)March 16, 2017
Actual (reported)April 11, 2017
Actual (reported)November 1, 2017
Actual (reported)November 1, 2017
Actual (reported)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
Difficulty of insertion of IUD in both groups
At time of insertion
side effects
from time of administration till insertion
Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Sixty women received the placebo vaginally six hours before IUD insertion. Placebo is the same in size, color and shape to misoprostol.
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 .
Kasr Alainy medical school
Cairo, 12151, Egypt
Ahmed Maged
Kasr Alainy medical school
120 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2017
First Posted
March 16, 2017
Study Start
April 11, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 1, 2017
Actual (reported)Study Completion
November 1, 2017
Actual (reported)Last Updated
November 6, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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