Clinical trial NCT03404622: Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
Official title: : Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mechanical Complication of Intrauterine Device
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

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

Primary outcomes:
measure: Expulsion
timeFrame: 3 months
Secondary outcomes:
measure: Displacement
timeFrame: 3 months
measure: Infection
timeFrame: 3 months
measure: Bleeding
timeFrame: 3 months
measure: Perforation
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Yasser M Aboutalib, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Ahmed S AbdelHamid, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: ALshaimaa A Ali, MBBch
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Haitham Torky, MD
role: STUDY_DIRECTOR
References:
citation: Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.