NCT02679820

Brief Summary

The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

February 8, 2016

Last Update Submit

January 6, 2019

Conditions

Contraception

Outcome Measures

Primary Outcomes (2)

  • Expulsion rate

    6 months

  • The percentage of females seeking contraception

    6 months

Study Arms (2)

PostPlacental IUD insertion

EXPERIMENTAL

Copper T intrauterine device will be inserted immediately following delivery of the placenta in cases of cesarean section deliveries.

Device: Copper T intrauterine device

Control

NO INTERVENTION

IUD will be offered as a method of contraception after puerperium

Interventions

Copper T intrauterine deviceDEVICE
Also known as: copper T IUD
PostPlacental IUD insertion

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

You may not qualify if:

  • refusal to participate in the study
  • desiring other methods of contraception
  • will not use any method of contraception
  • has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr el aini hospital

Cairo, 12211, Egypt

Location

Related Publications (1)

  • Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.

    PMID: 33006501DERIVED

Study Officials

  • Dina MR Dakhly, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 8, 2016

First Posted

February 10, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

EG(1)