Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

Phase 1

Completed

• Conditions: Mechanical Complication of Intrauterine Device
• Interventions: Drug: IUCD

• Registration Number: NCT03404622
• Lead Sponsor: ALshaimaa Aboalhassan Ali

Brief Summary

The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)

Detailed Description

Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .

Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.

Study Timeline

• Study Start: 2016-09-20
• Primary Completion: 2016-12-20
• Study Completion: 2017-12-20
• Status Verified: 2018-01
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-18
• Study First Posted: 2018-01-19
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Age: 18 -45
• Singleton pregnancy at ≥32 weeks gestation at time of enrollment
• Voluntarily requesting to IUD placement for postpartum contraception
• Able to give consent and agree to the terms of the study

Exclusion Criteria

1. Uterine anomaly that preventing replacement of IUD.
2. Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
3. Puerperal sepsis and unresolved postpartum hemorrhage.
4. IUD allergy (copper).
5. Systemic lupus erythematosus with severe thrombocytopenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postplacental IUCD Insertion during Cesarean section	IUCD	IUCD inserted postplacental removal
6 Week Post-Cesarean Insertion of IUCD	IUCD	IUCD inserted after six weeks post Cesarean section delivery

Primary Outcome Measures

Name	Time	Method
Expulsion	3 months	The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial

Secondary Outcome Measures

Name	Time	Method
Infection	3 months	The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study.
Displacement	3 months	The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word
Bleeding	3 months	Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist.
Perforation	3 months	The diagnosis of a perforation may be made by a transvaginal sonogram that shows no IUD within the uterus and an abdominal radiograph that show IUD within the abdominal cavity.

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt