Clincosm LogoSign in Get a demo

Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04718337
Collaborator
(none)
75
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The assessment of efficacy and patient safety of immediate postpartum IUD insertion using a novel technique.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The postpartum period is so critical time for both the mother and newborn that needs special health care because there are high morbidity and mortality rates during it (1).

    The World Health Organization (WHO) recommends that a woman should wait at least 24 months after delivery before the next pregnancy to decrease the adverse maternal, perinatal ,and infant outcomes (2, 3).

    A woman's fertility may begin to return rapidly and ovulate within 4:6 weeks postpartum particularly if she is not exclusively breastfeeding. In addition , more than 50% of women become sexually active by 6 weeks postpartum (4, 5).

    So, it is important to provide highly effective contraception immediately after delivery before leaving the delivery setting especially in communities where women cannot return easily for follow up visits due to financial and social barriers or who have limited access to medical service (6, 7).

    The use of effective postpartum contraception particularly longـacting reversible contraception (LARC) methods like the intrauterine device (IUD) has been shown to decrease the risk of unintended pregnancy and its complications and avoid repeated caesarean sections with higher continuation rates of use than other methods 6 months after delivery (8-10).

    Immediate post placental intraـcaesarean IUD insertion has many advantages as it is effective reversible longـterm contraception, doesn't interfere with breastfeeding, is coitus independent and the woman can avoid discomfort and pain during the standard insertion and bleeding from insertion will be masked by lochia (11-14).

    Studies have shown that with effective provider training, the immediate postpartum IUD insertion (IPPIUD) complications such as expulsion, pelvic infection, bleeding, pain, missing threads ,and failure rates are not significantly different from those of interval PPIUD insertion (4:6 weeks) after delivery (15, 16).

    By using a novel technique in this study, these complications would be decreased.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique
    Anticipated Study Start Date :
    Jun 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy of postpartum intra-caesaren IUD insertion [6 months]

      the evaluation of efficacy of this novel technique to decrease the rates of expulsion, missing threads and failure.

    Secondary Outcome Measures

    1. Patient safety of postpartum intra-caesarean IUD insertion [6 months]

      the evaluation of patient safety including pelvic infections, lower abdominal pain and excessive bleeding.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Women admitted to undergo CS.

    2. Singleton pregnancy.

    3. Delivery of a liveـborn infant with gestational age < 36 weeks.

    4. Informed and written consent to participate in the study.

    Exclusion Criteria:

    1. History of dysmenorrhea, menorrhagia or coagulopathies.

    2. Uterine anomalies or fibroids.

    3. Antepartum or intrapartum hemorrhage.

    4. Prolonged rupture of membranes <24 hours with or without chorioamnionitis.

    5. Intrapartum fever.

    6. History of current, recent (within previous 3 months) or recurrent pelvic infilammatory diseases (PID).

    7. History of ectopic pregnancy.

    8. Multiple pregnancy.

    9. Active cervicitis, vaginitis or sexual transmitted diseases (STD) on gyaecological examination.

    10. Allergy to any component of the IUD or Wilson's disease.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Christine Tamer Laisha, Doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04718337
    Other Study ID Numbers:
    • Postpartum IUD insertion
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 22, 2021