Predictors for Discontinuation of Post Placental Intrauterine Contraceptive Device (PPIUCD) at Two-year Point With Implications for Population Stabilization in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- continuation rate of PPIUCD at 24 months.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Postpartum Intrauterine Contraceptive Device (PPIUCD). (Device)
结局指标
主要结局
continuation rate of PPIUCD at 24 months.
时间窗: 24 months post-insertion
The percentage of participants who continue using the postpartum intrauterine contraceptive device (PPIUCD) at 24 months after insertion.
次要结局
- 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)
研究者
Tayyiba Wasim
Professor Obstetrics & Gynaecology
Services Institute of Medical Sciences, Pakistan
