Postpartum Intra-caesarean Intrauterine Device Insertion Using a Novel Technique

• Conditions: IUD Complication

• Registration Number: NCT04718337
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-09-26
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-16
• Last Update Submitted: 2021-01-16
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Study Start: 2021-06-01
• Primary Completion: 2022-06
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patient safety of postpartum intra-caesarean IUD insertion	6 months	the evaluation of patient safety including pelvic infections, lower abdominal pain and excessive bleeding.