New Method of IUD Insertion During Cesarian Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- visibility of the threads of IUD.
研究概览
简要总结
In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.
详细描述
Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant , full term patients , scheduled for elective CS.
排除标准
- •contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
- •Patients with intra-operative bleeding or vital instability.
- •Active genital infection at time of insertion.
- •Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.
研究组 & 干预措施
classic technique
干预措施: cesarian section (Procedure)
classic technique
干预措施: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) (classic technique) (Device)
new technique
干预措施: Copper T380 IUD ( Paragard 380 A ,CooperSurgical, Inc. © 2022) ( New technique) (Device)
new technique
干预措施: cesarian section (Procedure)
结局指标
主要结局
visibility of the threads of IUD.
时间窗: 3 months
using a cusco speculum , the IUD threads are inspected.
accuracy of IUD position.
时间窗: 3 months
using ultrasound the position of IUD by measuring the distance between the IUD \& the fundus of the uterus.
次要结局
- complications of IUD(1 month)
- patient overall satisfaction about the new technique(3 months)
研究者
Bassiony Dabian
lecturer of obstetrics and gynecology
Cairo University
