Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02141321

Enrollment

124

Registered

2014-05-19

Start date

2014-05-31

Completion date

2015-01-31

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion

Keywords

IUD, Misoprostol, Rectal administration

Brief summary

The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

Detailed description

The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Interventions

DRUGMisoprostol

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Normal size uterus. * Willing to participate. * Candidate for IUD insertion. * Delivered only by cesarean section. * Last delivery is more than 40 days before participating in the study.

Exclusion criteria

* Previous vaginal delivery * Signs of genital infection. * Menopause. * Body mass index (BMI) \> 35 kg/m2. * Contraindication to misoprostol. * Copper allergy. * Positive pregnancy test. * Had a prior attempt for IUD insertion. * Uterine anomalies. * Uterine fibroid.

Design outcomes

Primary

Measure	Time frame	Description
Pain	During the procedure	The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain.

Secondary

Measure	Time frame	Description
Difficulty of Procedure	During the procedure	The degree of difficulty of the IUD insertion judged by the investigator as the resistance met at the internal cervical os. The procedure either graded as (easy), (moderate difficulty) or (difficult) or (failed insertion).
Complications	During the procedure and the following 24 hours.	Uterine perforation, excessive bleeding, fever, IUD expulsion or any other unexpected complications will be assessed during the procedure and followed for the next 24 hours.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026