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Postpartum ContraceptionNCT06766396

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

A study testing Postpartum Intrauterine Contraceptive Device (PPIUCD). in people with Postpartum Contraception and Reproductive Health, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Postpartum Intrauterine Contraceptive Device (PPIUCD).
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,400 participants
Where
1 sitePakistan
Study dates
1 Nov 2017to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Services Institute of Medical sciences

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Predictors for Discontinuation of Post Placental Intrauterine Contraceptive Device (PPIUCD) at Two-year Point With Implications for Population Stabilization 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.

Read the 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.

Being tested
Postpartum Intrauterine Contraceptive Device (PPIUCD).
Keywords
Postpartum intrauterine contraceptive device, maternal Health, Population stabilization, contraception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT06766396
Study groupRoleWhat they receive
Postpartum Intrauterine Contraceptive Device (PPIUCD) InsertionExperimentalParticipants 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.
Receives: Device: Postpartum Intrauterine Contraceptive Device (PPIUCD).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months post-insertion

Secondary outcomes (3)
  1. Complication Rate Associated with PPIUCD Use

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

    Measured: From insertion to 24 months post-insertion

  2. Reasons for PPIUCD Discontinuation

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

    Measured: From insertion to 24 months post-insertion

  3. Expulsion Rate of PPIUCD

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

    Measured: From insertion to 24 months post-insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start1 Nov 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
3,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06766396
Sponsor's protocol ID
IRB/2017/373/SIMS
Status last verified
Jan 2025
First submitted
27 Dec 2024
Last updated
9 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Postpartum Intrauterine Contraceptive Device (PPIUCD). in people with Postpartum Contraception and Reproductive Health, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

continuation rate of PPIUCD at 24 months. (time frame: 24 months post-insertion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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