Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery

NCT04080349 — Phase 4, Unknown, 300 participants, Cairo University

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Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery:a Randomized Controlled Trial

Registry	NCT04080349
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	300 (Estimated)
Sponsor	Cairo University (Other)
Conditions	IUD Pain
Interventions	Dinoprostone 3 mg, Misoprostol 200Mcg Tab, placebo (Drug)
Dates	start 2019-09-10 (estimated), primary completion 2019-11-30 (estimated), completion 2019-12-05 (estimated), first posted 2019-09-06, last updated 2019-09-06

-Summary

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

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+Detailed description

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

+Arms and interventions

Arm	Type	Interventions	Description
dinoprostone	Experimental	Drug: Dinoprostone 3 mg	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
misoprostol	Active comparator	Drug: Misoprostol 200Mcg Tab	1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
placebo	Placebo comparator	Drug: placebo	one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Dinoprostone 3 mg (Drug): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
Misoprostol 200Mcg Tab (Drug): 1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
placebo (Drug): one tablet of placebo inserted by the study nurse 3 hours before IUD insertion

+Outcome measures

Primary outcomes

The difference in pain scores during intrauterine device insertion [10 minutes]: The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion Criteria:

* contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.

+Investigators

AHMED SAMY, Principal investigator, Cairo University