Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion

• Sponsor: Assiut University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03106805
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The optimal interval between pregnancies is debated, but a duration greater than 11-18 months has been suggested as reducing complications in the subsequent pregnancy. Improved birth spacing can be a key benefit use of long-acting reversible contraception, but delay to initiation can still be problematic.So women who have recently given birth can be cost-effectively targeted for family planning education and engagement because often they are already connected with health professionals

Condition or Disease	Intervention/Treatment	Phase
Contraception Behavior	Procedure: early insertion; Procedure: late insertion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Nov 1, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: insertion by the end of the 4th week postpartum	Procedure: early insertion; insertion at 4th postpartum week
Active Comparator: insertion by the end of the 6th week postpartum	Procedure: late insertion; insertion at 6th postpartum week

Outcome Measures

Primary Outcome Measures

1. The number of participants use the device [6 weeks]

   number of women place the intrauterine device within 6 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Delivered (vaginal or Cesarean) a singleton living baby ≥28weeks gestation. Women desire birth spacing for one year or more. Women who will accept to participate in the study and follow up.

Exclusion Criteria:

1. Known uterine anomalies.

2. Women with previous ectopic pregnancy.

3. Presence of postpartum pyrexia.

4. Women with history of postpartum hemorrhage in the last delivery either primary or secondary.

5. Retained products of conception.

6. History of previous uterine perforation.

7. Anticipation of difficulty of subsequent follow-up with the women.

8. Women with uncontrolled diabetes and hypertension.

9. Women who wish to use other contraceptive methods.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

• Principal Investigator: Ahmed Abbas, MD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Shachar BZ, Mayo JA, Lyell DJ, Baer RJ, Jeliffe-Pawlowski LL, Stevenson DK, Shaw GM. Interpregnancy interval after live birth or pregnancy termination and estimated risk of preterm birth: a retrospective cohort study. BJOG. 2016 Nov;123(12):2009-2017. doi: 10.1111/1471-0528.14165. Epub 2016 Jul 13.

• Responsible Party: Ahmed Mohamed Abbas, Clinical Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT03106805
• Other Study ID Numbers: EAIUD
• First Posted: Apr 10, 2017
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Mohamed Abbas, Clinical Professor, Assiut University: intrauterine device

Study Results

No Results Posted as of May 11, 2022