NCT03492034

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.7 years

First QC Date

March 24, 2018

Last Update Submit

May 26, 2020

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

  • IUD expulsion rate

    6 weeks

Secondary Outcomes (4)

  • Bleeding

    6 weeks

  • Degree of Pain

    6 weeks

  • dyspareunia

    6 weeks

  • patient satisfaction

    6 weeks

Study Arms (2)

IUD during CS

ACTIVE COMPARATOR
Device: IUD during CS

IUD after puerperium

ACTIVE COMPARATOR
Device: IUD after puerperium

Interventions

IUD during CSDEVICE

IUD insertion during CS

IUD during CS
IUD after puerperiumDEVICE

IUD after puerperium

IUD after puerperium

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

Related Publications (1)

  • Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

    PMID: 36302159DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2018

First Posted

April 10, 2018

Study Start

April 1, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

EG(1)