Clinical trial NCT05204979: Vaginal Vs Subling Misoprost Before Iud Insertion in Women With Previous CS
Official title: Vaginal Versus Sublingual Misoprostol Before Intrauterine Device Insertion in Women With Pervious Caesarian Section
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IUD Insertion
Keywords: Misoprostol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted on multiparous women delivered only by CS seeking intra uterine device insertion

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Women at the reproductive age group between 20-40 years Women who previously delivered by cesarean section. Women with BMI between 20- 30.

Exclusion Criteria:

Women had a previous vaginal operations. Women with contraindications for misoprostol use (pregnancy, prostaglandin allergy) Women with a contraindication for IUCD insertion (e.g., less than sex weeks post-partum, gynecologic malignancy, uterine bleeding of undetermined origin, fibroids or other uterine abnormalities, active vaginitis or cervicitis, a history of PID or puerperal sepsis).

Women on anticoagulant therapy or having any coagulopathy. Women who refused to participate.

Primary outcomes:
measure: The proportion of easy IUD Insertion
timeFrame: 24 hours
Secondary outcomes:
measure: the pain during insertion
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: professor
name: Hassan MD awad, consultant
role: STUDY_CHAIR
affiliation: doctor
name: Rofida M Taha, doctor
role: STUDY_CHAIR
References: