IUD Insertion During Cesarean Section

May 26, 2020 updated by: Mohamed S Sweed, MD, Ain Shams University

Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial

Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant woman aged between 18 to 40 years old.
  2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
  3. Body mass index between 19-30 kg/m2
  4. Seeking contraception after delivery.

Exclusion Criteria:

  1. History of menorrhagia or severe dysmenorrhea.
  2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
  3. Patients who have bleeding disorders.
  4. Anemia (Hb < 9 g %).
  5. Chronic depilating diseases reducing immunity such as Diabetes.
  6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
  7. History of previous IUD expulsion or removal for complications.
  8. Unexplained uterine bleeding.
  9. Copper allergy or Wilson disease.
  10. Gestational trophoblastic disease with persistently elevated Beta HCG.
  11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
  12. Complications during cesarean section e.g. postpartum hemorrhage.
  13. Cesarean section during placenta previa.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IUD during CS
Device: IUD during CS
IUD insertion during CS
Active Comparator: IUD after puerperium
Device: IUD after puerperium
IUD after puerperium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IUD expulsion rate
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 6 weeks
number of pads changed per day
6 weeks
Degree of Pain
Time Frame: 6 weeks
Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)
6 weeks
dyspareunia
Time Frame: 6 weeks
Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)
6 weeks
patient satisfaction
Time Frame: 6 weeks
Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • AS1750

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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