: Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
Overview
- Phase
- Phase 1
- Intervention
- IUCD
- Conditions
- Mechanical Complication of Intrauterine Device
- Sponsor
- ALshaimaa Aboalhassan Ali
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Expulsion
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
ALshaimaa Aboalhassan Ali
physician
Ain Shams University
Eligibility Criteria
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
- •Uterine anomaly that preventing replacement of IUD.
- •Chorioamnionitis (such as prolonged rupture of membranes \>18 hours, prolonged labor \>24 hours, fever \>38C).
- •Puerperal sepsis and unresolved postpartum hemorrhage.
- •IUD allergy (copper).
- •Systemic lupus erythematosus with severe thrombocytopenia
Arms & Interventions
Postplacental IUCD Insertion during Cesarean section
IUCD inserted postplacental removal
Intervention: IUCD
6 Week Post-Cesarean Insertion of IUCD
IUCD inserted after six weeks post Cesarean section delivery
Intervention: IUCD
Outcomes
Primary Outcomes
Expulsion
Time Frame: 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 Outcomes
- Infection(3 months)
- Displacement(3 months)
- Bleeding(3 months)
- Perforation(3 months)