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Clinical Trial Summary

Insertion failures of intrauterine devices and cervical problems seem to occur more often among women who have never delivered vaginally. This trial will compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS.


Clinical Trial Description

Intrauterine devices (IUDs) are widely used as reversible contraceptives. The current use of IUDs among reproductive-aged women ranges from 8 to 15% worldwide. Reported complications related to IUD insertion are 8.8% insertion failure, 2.8-11.5% cervical problems, 0.2% cervical perforation, 0.2% syncope and 5.8% expulsion. Insertion failures and cervical problems seem to occur more often among women who have never delivered vaginally. Misoprostol is an inexpensive PGE1. Priming with misoprostol prior to hysteroscopy and dilatation and curettage (D&C) in premenopausal women resulted in an increased cervical dilatation and rate of cervical laceration. Moreover, several studies have shown the benefit of misoprostol as a cervical ripening agent in nonpregnant women. The effect of misoprostol is dependent on the route of administration. Sublingual administration of misoprostol has been shown to be more effective also for cervical priming compared with oral administration and equally effective as vaginal administration. larger studies on the effect of misoprostol for IUD insertion are lacking. Investigator therefore will conduct a trial aiming to compare the effect of vaginal versus sublingual misoprostol prior to insertion of an intrauterine device in multiparous women delivered by CS. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05204979
Study type Observational
Source Ain Shams University
Contact Rofida M Taha, doctor
Phone +2 01284604696
Email [email protected]
Status Recruiting
Phase
Start date June 23, 2021
Completion date May 25, 2022

See also
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Not yet recruiting NCT03473717 - Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method N/A
Completed NCT02738203 - Self-Administered Lidocaine Gel for Pain Management With IUD Insertion Phase 3
Completed NCT04441333 - Usability, Safety and Efficacy of AspivixTM N/A
Completed NCT02904915 - Paracervical Block Versus No Paracervical Block During IUD Insertion Phase 4
Completed NCT04046302 - Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women. Phase 4
Completed NCT04441281 - Usability, Safety and Efficacy of AspivixTM (Comparative Study) N/A