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

NCT ID: NCT06766396

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2022-12-31

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.

Detailed Description

This prospective cohort study was conducted in the Department of Obstetrics and Gynecology at Services Hospital, Lahore, Pakistan, from November 2017 to December 31, 2022, after receiving ethical approval from the Institutional Review Board (Ref No. IRB/2017/373/SIMS). The study aimed to evaluate the continuation rates, complications, and satisfaction associated with postpartum intrauterine contraceptive devices (PPIUCDs) as a method of long-acting reversible contraception (LARC). The Government of Punjab provided contraceptive supplies free of cost to support the study.

Pregnant women attending antenatal care were recruited for the study after being educated about the importance of contraception using the GATHER counseling technique. Women who expressed interest in LARC, including PPIUCD, were provided detailed information about its benefits and risks. Informed consent was obtained, and their socio-demographic data were documented using a structured questionnaire. Willingness to participate was noted by stamping the antenatal cards of consenting women.

PPIUCDs were inserted immediately postpartum for both vaginal and cesarean deliveries. For vaginal deliveries, Kelly's forceps were used under aseptic conditions. During cesarean deliveries, PPIUCDs were inserted before the uterine incision was closed. All insertions were performed by healthcare providers trained by master trainers to ensure standardized techniques and minimize complications. Each participant received a follow-up card containing information about potential issues, such as irregular bleeding or difficulty in feeling the thread, and instructions to report these problems promptly.

The structured questionnaire developed for the study captured key socio-demographic and clinical information, including age, parity, education, occupation, monthly income, family size, and access to smartphones or Wi-Fi. Data on prior contraceptive use, reasons for non-use (e.g., myths or religious beliefs), and motivations for choosing PPIUCD (e.g., convenience, family influence, or doctor counseling) were also collected.

Participants were followed up at 3 months, 6 months, 1 year, and 2 years after insertion, either through in-person visits or telephonic interviews. During these follow-ups, data on complications such as irregular or heavy menstrual bleeding, pelvic pain, vaginal discharge, or device expulsion were recorded. Women were asked about their satisfaction with PPIUCD use and whether they continued or discontinued the method. For those who reported issues, a speculum examination was offered to check the thread position and trim it if necessary. Detailed information about device removal or expulsion, including the timing and reasons, was also collected during follow-ups.

The primary outcome of the study was the continuation rate at 24 months, defined as the probability of women consistently using the PPIUCD during this period. Secondary outcomes included reasons for discontinuation, and complications experienced.

Data analysis was performed using SPSS version 23. Qualitative variables were expressed as proportions with 95% confidence intervals (CIs). Comparative analyses between groups were conducted using the Chi-square test or Fisher's Exact test, depending on the data characteristics. A p-value of ≤ 0.05 was considered statistically significant.

Conditions

Postpartum Contraception; Reproductive Health; Family Planning

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Postpartum Intrauterine Contraceptive Device (PPIUCD) Insertion

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.

Group Type: EXPERIMENTAL

Postpartum Intrauterine Contraceptive Device (PPIUCD).

Intervention Type: 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

Interventions

Postpartum Intrauterine Contraceptive Device (PPIUCD).

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tayyiba Wasim

Professor Obstetrics & Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tayyiba Wasim, FCPS

Role: PRINCIPAL_INVESTIGATOR

Services Institute of Medical Sciences, Pakistan

Locations

Services Institute of Medical sciences

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IRB/2017/373/SIMS

Identifier Type: -

Identifier Source: org_study_id