: Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Expulsion
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
盲法说明
Randomization will be based on the sequence generation created by computer and randomization tablets. Consenting patients fulfilling inclusion criteria will be randomizes into one of the following 2 groups. Randomized allocation will be kept in opaque sealed envelopes, with enrollment numbers written on the envelopes. the envelopes will contain a card on with the designated study group will be written. after enrollment of the patients in the study , the envelopes marked with study number will be unsealed and the patients allocated to either groups
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Postplacental IUCD Insertion during Cesarean section
IUCD inserted postplacental removal
干预措施: IUCD (Drug)
6 Week Post-Cesarean Insertion of IUCD
IUCD inserted after six weeks post Cesarean section delivery
干预措施: IUCD (Drug)
结局指标
主要结局
Expulsion
时间窗: 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
次要结局
- Infection(3 months)
- Displacement(3 months)
- Bleeding(3 months)
- Perforation(3 months)
研究者
ALshaimaa Aboalhassan Ali
physician
Ain Shams University