Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Patient compliance
研究概览
简要总结
After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus delayed insertion on patient's compliance in Ain Shams University Maternity Hospital (ASUMH).
详细描述
- After protocol approval by the ethical committee of the department of Obstetrics & Gynecology, Faculty of Medicine, Ain Shams University; pregnant woman planning to undergo elective cesarean section in ASUMH were recruited from the antenatal clinic.
- Counselling was done about different postpartum contraceptive methods including immediate PPIUD and delayed IUD insertion.
- An informed written consent was taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
- History taking, examination, and investigations (CBC, follow-up Ultrasound) were done to identify eligible patients according to the inclusion and exclusion criteria.
- Randomization: Eligible patients were quasi-randomized into 2 groups:
Group (A) (PPIUD group): immediate postplacental IUD insertion. Group (B) (delayed insertion group): delayed IUD insertion at the 6th week postpartum visit.
Randomization was done through "Alternation" method.
- Allocation: the first patient (no.1) was allocated to group (A) and second patient (no.2) to group (B) and so on by ''Alternation method '' till fulfilling the sample size.
Procedure:
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
- None
盲法说明
masking is not applicable
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women planned for delivery by cesarean section in Ain Shams University Maternity hospital
排除标准
- •Women not consenting to use IUD as a contraceptive method and preferring other methods.
- •Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use World Health Organization (WHO) 2015
- •Neuropsychiatric disorder causing altered mentality or perception
- •Intrapartum complications as chorioamnionitis, massive blood loss, or hysterectomy.
- •Anemic patients (hemoglobin level <10g/dl).
结局指标
主要结局
Patient compliance
时间窗: at 12 months after the procedure
compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method? 1 = Yes 0 = No
次要结局
- dyspareunia(at 12months after the procedure)
- Efficiency(at 12 months after the procedure)
- Abnormal Bleeding pattern(at 12 months after the procedure)
- Anemia(at 12months after the procedure)
研究者
Rania Hassan Mostafa
Principal investigator
Ain Shams Maternity Hospital