Immediate Post Placental Insertion of Intrauterine Device at Cesarean Delivery, is Acceptable, Feasible and Safe in Iraqi Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cost of IUD insertion during the immediate postpartum period.
研究概览
简要总结
Iraq is a country that ranks 33rd around world population growth rate. Meanwhile it is one of the counties in the middle east with the highest fertility rate, In addition to the considerable number of unintended pregnancy mainly in postpartum period.
The less use of family planning methods, the higher the fertility rate and the less interpregnancy interval which will carry an obvious more risk to the mother and the fetus especially if the cesarean delivery rate shown an increase trend as the case in Iraq. For that reason, contraception needs to be practiced in this critical period and an intrauterine contraceptive device ( IUD), the most commonly used reversible method of contraception worldwide could be an excellent choice during this period.
There were few evidences available about the safety and feasibility on practicing this type of contraception when we did start three years ago and no previous evidences in Iraq about practicing this method at the immediate postpartum period.
详细描述
Setting and design:
It is a single arm prospective clinical trial. That had been conducted at Al Elweyia Maternity Teaching Hospital and Al Hayat Private Hospital in Baghdad during the period from Sept., 1st, 2015 to Jan.,1st, 2019. Women delivering in those hospitals fulfilling inclusion criteria were included in the study after obtaining informed consent. The study protocol was approved by the ethical committee.
Data collection:
180 women were enrolled in the study, only 150 of them completed the study as thirty women we couldn't reach them through their contact numbers.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Women who delivered by caesarean section whether elective or emergency, counseled for IUD insertion in pre- natal period or at the time of labour and who has the will and her husband to be engaged in the study.
排除标准
- •Women with positive test for STIs (e.g. gonorrhea or chlamydia) in this pregnancy.
- •Uterine anomaly that was known to distort the uterine cavity; whether uterine fibroid or congenital uterine anomalies.
- •Developed postpartum hemorrhage.
- •Diagnosed chorioamnionitis, intrapartum fever, or ruptured membranes for greater than 24 hours prior to delivery.
- •Placenta previa or accrete.
- •Anemia during pregnancy (Hb < 10 g/dl).
研究组 & 干预措施
Post placental intra uterine device insertion
There was immediate post-partum insertion of CuT 380 A intrauterine device after delivery of placenta during cesarean delivery. To overcome the considerable expulsion rate in the previous studies, we stabilize the IUD in place at the fundus be an absorbable suture; vicryl 0 that was introduced through the fundus, held the needle with sponge holder that was introduce up the fundus and taken out the vicryl through the lower uterine inscion, cutting the needle, hold the vicryl around the the T arm of the IUD and withdrawn back to be placed inside the fundus. Before closing the uterine incision, the threads were placed in the lower uterine segment, then the uterine incision was then closed routinely.
干预措施: Copper Intra uterine contarceptive device ( Cu-T 380A) (Device)
结局指标
主要结局
Cost of IUD insertion during the immediate postpartum period.
时间窗: Up to 3 years.
Assessing the cost for the insertion of the device in the immediate postpartum period.
Time spent for IUD insertion during the immediate postpartum period
时间窗: Up to 3 years
Assessing the extra time spent for the insertion of the device in the immediate postpartum period.
Number of the women accept to be engaged in this services.
时间窗: First 6 months of the study
Assessing the acceptability of the women for the service of IUD insertion during the immediate postpartum period after cesarean delivery.
次要结局
- Percentage of Immediate complications(First 48 hours post cesarean section.)
- Percentage of other complications(Six months and yearly up to 3 years)
研究者
Taghreed Alhaidari
Assistant Professor/ Consultant Obstatricain & Gynecologist / Head of Scientific Affairs Unit
Al-Kindy College of Medicine