Predictors of PPIUCD Discontinuation at Two Years: A Clinical Study in Pakistan

NCT06766396 | Completed

• 1 other identifier: IRB/2017/373/SIMS
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective cohort study evaluated the continuation rates, complications, and satisfaction associated with postpartum intrauterine contraceptive devices (PPIUCDs) as a long-acting reversible contraception (LARC) method. Conducted in the Department of Obstetrics and Gynecology at Services Hospital, Lahore, Pakistan, from November 2017 to December 31, 2022, the study enrolled pregnant women attending antenatal care. Counseling was conducted using the GATHER technique, and informed consent was obtained before insertion. PPIUCDs were inserted postpartum during vaginal or cesarean deliveries by trained healthcare professionals. Follow-ups at 3, 6, 12, and 24 months assessed continuation rates, complications, and reasons for discontinuation.

Conditions

Postpartum Contraception; Reproductive Health; Family Planning

Keywords

Postpartum intrauterine contraceptive device; maternal Health; Population stabilization; contraception

Outcome Measures

Primary Outcomes (1)

• continuation rate of PPIUCD at 24 months.

  The percentage of participants who continue using the postpartum intrauterine contraceptive device (PPIUCD) at 24 months after insertion.

  24 months post-insertion

Secondary Outcomes (3)

• Complication Rate Associated with PPIUCD Use

  From insertion to 24 months post-insertion

• Reasons for PPIUCD Discontinuation

  From insertion to 24 months post-insertion

• Expulsion Rate of PPIUCD

  From insertion to 24 months post-insertion

Study Arms (1)

Postpartum Intrauterine Contraceptive Device (PPIUCD) Insertion

EXPERIMENTAL

Participants in this arm will receive the intervention of a postpartum intrauterine contraceptive device (PPIUCD) insertion. The PPIUCD will be inserted immediately postpartum for vaginal deliveries using Kelly's forceps under aseptic conditions or during cesarean section prior to uterine incision closure. All insertions will be performed by trained healthcare professionals to ensure consistency. Participants will be followed prospectively for up to 24 months to assess continuation rates, complications, and satisfaction with the method.

Device: Postpartum Intrauterine Contraceptive Device (PPIUCD).

Interventions

Postpartum Intrauterine Contraceptive Device (PPIUCD). DEVICE

Participants in the intervention arm will receive a postpartum intrauterine contraceptive device (PPIUCD) immediately after delivery. For vaginal deliveries, the PPIUCD will be inserted manually using Kelly's forceps under aseptic conditions, while for cesarean deliveries, the device will be inserted before uterine incision closure. All insertions will be performed by trained healthcare professionals

Postpartum Intrauterine Contraceptive Device (PPIUCD) Insertion

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women attending antenatal care at the Department of Obstetrics and Gynecology, Services Hospital Lahore.
• Willing to use postpartum intrauterine contraceptive device (PPIUCD) as a method of contraception.
• Provided informed consent for participation in the study.
• Delivered via vaginal delivery or cesarean section with no contraindications to PPIUCD insertion.

You may not qualify if:

• Known uterine anomalies or severe uterine bleeding post-delivery.
• Diagnosed with chorioamnionitis or puerperal sepsis during delivery or postpartum.
• Known hypersensitivity or contraindications to copper-based intrauterine devices.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Study Officials

• Tayyiba Wasim, FCPS

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obstetrics & Gynaecology

Model Details: This study uses a single-group assignment model where all eligible postpartum women who consent to participate receive the intervention of postpartum intrauterine contraceptive device (PPIUCD) insertion. The intervention is provided either immediately postpartum for vaginal deliveries using Kelly's forceps or during cesarean section before uterine closure. Participants are followed prospectively for up to 24 months to evaluate continuation rates, complications, and reasons for discontinuation of PPIUCD.

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 9, 2025
• Study Start: November 1, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)