Comparative Study of Intrauterine Contraceptive Device Insertion During Caesarean Section Versus Conventional Application
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 8
- 主要终点
- Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound
研究概览
简要总结
The study aims to compare immediate post-placental (within 10 minutes of placenta delivery) intrauterine contraceptive device (Copper T 380A) insertion versus conventional placement at 6 weeks (often referred to as delayed or interval insertion) regarding the clinical outcomes (safety, efficacy, expulsion and continuation rates) for women undergoing caesarean section.
详细描述
• Study Design: A controlled randomized clinical trial (CRCT)
• Study Site: The study will be carried out in the Department of Obstetrics and Gynecology at Beni-suef University Hospital
• Study Population: The study population will include pregnant women between 36-40 weeks gestational ages who attend antenatal care and are eligible for insertion of IUCD during delivery through elective caesarean section.
• Study Sample: The study will consist of 200 women which will be chosen randomly to whom elective lower segment caesarean section will be done at the Obstetrics and Gynecology department, willing to have an intrauterine device (IUD) inserted for postpartum contraception and willing to comply with the study protocol.
After informed consent is obtained, eligible study participants will be randomized into 2 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 years.
- •GA 36-40 weeks based upon the date of last normal menstruation, confirmed by ultrasonographic scan.
- •Desire to have intrauterine contraceptive device (Cu T) after counseling about different contraceptive options and consented to the study.
排除标准
- •Allergy to copper.
- •Ante- or intra-partum hemorrhage.
- •Hemorrhagic disorders.
- •Current or past history of pelvic inflammatory disease.
- •Women known to have pelvic TB.
- •Known to have ruptured membranes for more than 24 h prior to delivery.
- •History of chorioamnionitis.
- •Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
- •Patients presented with febrile morbidity prior to the operation defined as temperature above 38'c.
- •Multiple pregnancies.
- •Placenta previa.
- •History of ectopic pregnancy.
- •Anemia (hemoglobin <10 g/dl).
- •Cervical cancer or carcinoma in situ.
- •Diagnosis of active cervical infection for standard insertion.
研究组 & 干预措施
IUD insertion 6 Weeks after delivery
Subjects randomized to interval placement will have their Copper T 380A IUD placed in the office at six weeks postpartum or later
干预措施: Copper T 380A IUD (Device)
Immediate Post-placental insertion
Subjects randomized to receive the Copper T 380A IUD within 10 minutes of delivery of the placenta during caesarean section.
干预措施: Copper T 380A IUD (Device)
结局指标
主要结局
Expulsion: Complete IUD expulsion will be verified clinically and by transvaginal ultrasound
时间窗: 6 months
Complete IUD expulsion will be verified clinically and by transvaginal ultrasound. An IUD will be considered to be partially expelled if a distance greater than 10 mm is measured between the vertical arm of the IUD and the junction between the endometrium and the uterine cavity)
次要结局
- Psychological (satisfied or not) using questionnaire(6 months)
- Strings not visible (assessed by speculum examination)(6 months)
- Uterine perforation (assessed by pelvic ultrasonography or X-ray)(6 months)
- Pelvic pain (using the 0-10 Numeric Pain Rating Scale)(6 months)
- Pregnancy (assessed by serum pregnancy test and pelvic ultrasound)(6 months)
- Pelvic infection: number of participants with Pelvic infection(6 months)
研究者
sara AbdAllah
Assistant lecturer of Obstetrics and Gynecology Faculty of Medicine- Beni-sueif University
Beni-Suef University