Comparing Expulsion Rates When Using "Hang Up" Intrauterine Device Insertion Technique to Postplacental and Postpartum Insertion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Expulsion rates
研究概览
简要总结
the investigators are trying to determine if this method of intrauterine device (IUD) insertion "hang up technique" has less expulsion rates than 6 week insertion or immediate post-placental insertion.
详细描述
This prospective multi-center clinical trial will be conducted at the Kasr Alainy maternity hospital, and AL-Zahra university hospital after approval from both ethics committees was obtained (OBGYN Scientific & ethics committee and Al-Zahra ethics committee). The study will enroll pregnant women attending the antenatal care clinic who have been scheduled for elective cesarean section after obtaining a signed informed consent from all participants.
The enrolled participants will be divided into 3 groups:
- Group A: will serve as our experimental group where the enrolled patients will have the IUD applied in the middle of the uterine cavity and then attached to the fundus of the uterus by an absorbable suture "Hang up technique" (Tjahjanto & Haryuni, 2014)
- Group B: will serve as our active comparator and will include patients where IUD will be inserted after 6 weeks post-partum.
- Group C: will serve as our control group where the enrolled patients will have the IUD just applied into the middle of the uterine cavity at the level of the fundus without attachment.
Randomization will be done by a computer-generated randomization table, and assignment into the various groups will be done by a sealed opaque envelope system which will be opened by the circulating nurse in the operating room during cesarean section.
In both groups A and C, a Copper T-380 IUD (TCU 380 A with safe load PREGNA INTERNATIONAL LTD® manufactured by PREGNA® - India) was placed in the middle of the uterine cavity, and the threads was passed through the cervix after dilatation by one finger.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
randomised computer generated table and closed envelope system
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Full term patients (≥ 37 weeks gestation).
- •Singleton pregnancy.
- •Elective cesarean section for an uncomplicated pregnancy.
- •Healthy uterine cavity (no fibroid and no congenital anomaly) (Previously documented by history taking and/or ultrasound before pregnancy, and to be re-confirmed intraoperative).
排除标准
- •Preterm labor.
- •Uterine fibroid distorting uterine cavity.
- •History suggestive of previous pelvic inflammatory disease (Fever due to vaginal infection, ovarian abscess, repeated offensive vaginal infection, hydro/pyo-salpinx) 2
- •Rupture of membrane more than 12 hours.
- •Multi-fetal pregnancy
- •Placenta previa.
- •Previous uterine surgery other than CS
- •Documented congenital uterine anomalies intraoperative.
- •History of IUD insertion before this pregnancy with side effects like "bleeding, ectopic pregnancy, expulsion, pelvic inflammatory disease"
- •Uterine atony after delivery.
研究组 & 干预措施
Hang up technique
where the enrolled patients will have the IUD applied in the middle of the uterine cavity and then attached to the fundus of the uterus by an absorbable suture "Hang up technique"
干预措施: IUD (Device)
Postpartum insertion
will include patients where IUD will be inserted after 6 weeks post-partum.
干预措施: IUD (Device)
Control
will serve as our control group where the enrolled patients will have the IUD just applied into the middle of the uterine cavity at the level of the fundus without attachment
干预措施: IUD (Device)
结局指标
主要结局
Expulsion rates
时间窗: 6months
IUD expulsion among the 3 groups at different intervals 24hours, 6 weeks, 3 and 6months postpartum
次要结局
- Temperature(24 hours)
- Irregular bleeding(6 months.)
- Vaginitis(6 months)
- postpartum hemorrhage(24 hours)
研究者
Ahmed M.Kamel
Asst. Professor of obstetrics and gynecology
Kasr El Aini Hospital