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Completed

NCT Number: NCT06766396

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. continuation rate of PPIUCD at 24 months.

    Time frame: 24 months post-insertion

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

Secondary outcomes

  1. Complication Rate Associated with PPIUCD Use

    Time frame: From insertion to 24 months post-insertion

    The percentage of participants reporting complications such as heavy or irregular menstrual bleeding, expulsion, pelvic pain, or vaginal discharge during the follow-up period.

  2. Reasons for PPIUCD Discontinuation

    Time frame: From insertion to 24 months post-insertion

    Documenting reasons for PPIUCD removal, including complications, misplaced ,wants another pregnancy or family pressures.

  3. Expulsion Rate of PPIUCD

    Time frame: From insertion to 24 months post-insertion

    The percentage of participants experiencing spontaneous expulsion of the PPIUCD during the follow-up period.

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Official study title

Predictors for Discontinuation of Post Placental Intrauterine Contraceptive Device (PPIUCD) at Two-year Point With Implications for Population Stabilization in Pakistan

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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