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Clinical Trials/NCT03106805
NCT03106805WithdrawnNot Applicable

Early (4th Week) Versus Late (6thweek) Interval Postpartum Copper Intrauterine Device Insertion: a Randomized Controlled Trial

Assiut University1 site in 1 countryStarted: July 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
The number of participants use the device

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
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

  • •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.

Arms & Interventions

insertion by the end of the 4th week postpartum

Experimental

Intervention: early insertion (Procedure)

insertion by the end of the 6th week postpartum

Active Comparator

Intervention: late insertion (Procedure)

Outcomes

Primary Outcomes

The number of participants use the device

Time Frame: 6 weeks

number of women place the intrauterine device within 6 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Abbas

Clinical Professor

Assiut University

Study Sites (1)

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