Early Versus Late Interval Postpartum Copper Intrauterine Device Insertion

Contraception Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03106805
• Other study ID #: EAIUD
• Status: Withdrawn
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 2022

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Procedure:
• early insertion
insertion at 4th postpartum week
• late insertion
insertion at 6th postpartum week

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants use the device	number of women place the intrauterine device within 6 weeks	6 weeks