Study Stopped
no participants
Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion
Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedMay 11, 2022
May 1, 2022
4.3 years
April 4, 2017
May 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of participants use the device
number of women place the intrauterine device within 6 weeks
6 weeks
Study Arms (2)
insertion by the end of the 4th week postpartum
EXPERIMENTALinsertion by the end of the 6th week postpartum
ACTIVE COMPARATORInterventions
insertion at 4th postpartum week
insertion at 6th postpartum week
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known uterine anomalies.
- Women with previous ectopic pregnancy.
- Presence of postpartum pyrexia.
- Women with history of postpartum hemorrhage in the last delivery either primary or secondary.
- Retained products of conception.
- History of previous uterine perforation.
- Anticipation of difficulty of subsequent follow-up with the women.
- Women with uncontrolled diabetes and hypertension.
- Women who wish to use other contraceptive methods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut Faculty of Medicine
Asyut, Egypt
Related Publications (1)
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.
PMID: 27405702BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Abbas, MD
Assiut University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 10, 2017
Study Start
July 1, 2017
Primary Completion
November 1, 2021
Study Completion
March 1, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share