The Safety and Efficacy of Immediate Post Placental IUD Insertion Versus the Post Puerperal IUD Insertion in Patients Undergoing Cesarean Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 主要终点
- IUD expulsion rate
研究概览
简要总结
Sixty six women who plan to deliver a live birth singleton via cesarean delivery who desire a Copper IUD for postpartum contraception will be approached for study participation thenvwill be randomized equally into two groups using computer generated numbers.
Group (A): (n=33) women IUD insertion post placental delivery (within 10mins) Group (B): (n=33) women IUD insertion post puerperal ( 6 to 8 weeks postpartum). Primary outcome will include IUD expulsion rate in both groups. Secondary outcomes will include other complications rates: missed threads (not seen by speculum examination), displaced IUD (more than 2 cm from the fundus in ultrasound), heavy puerperal bleeding, abdominal discomfort), Pregnancy rate, Discontinuation of the IUD usage and Satisfaction rate.
详细描述
Full history taking including a detailed history including medical and obstetric history, full obstetric examination and ultrasound evaluation to confirm gestational age and to exclude any of the exclusion criteria. Women who plan to deliver a live birth singleton via cesarean delivery at Kasr El-Ainy teaching will be considered for inclusion in the study. Women who desire a Copper IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan will be documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at El-Kasr El-Ainy teaching hospital. The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).
For women randomized to the immediate post placental IUD insertion (n=33) the following will be done:
- after placental delivery, uterine cavity will be examined to exclude the presence of malformations or fibroids.
- Uterus will be stabilized by grasping it at fundus and the copper IUD (CuT 380 PREGNA IUD) will be placed (within 10 minutes following the placental delivery) through the uterine wall incision high up in the uterine fundus (either by hand or using its applicator).
- Before closing the uterine incision, the IUD strings will be guided to the lower uterine segment without trimming (If the cervix is closed, it should be dilated from above using a dilator).
- Enough care should be taken not to dislodge the IUD from its fundal position or to include the strings in uterine sutures.
- The IUD threads will protrude through the cervix in some cases its trimming will be done during follow-up if the patient is feeling any discomfort.
- Before discharge, the patient will be given a card including the intervention done (date & procedure), the follow-up schedule and investigator contacts. Also, they will be informed about normal postpartum symptoms, IUD side effects & possible complications (abdominal cramps, heavy puerperal bleeding, expulsion or protrusion of string) and instruct to seek medical help (to call the principle investigator) if any of the following warning signs have happened (severe lower abdominal pain, severe vaginal bleeding, infected discharge or lochia, fever, IUD expulsion & suspicion of pregnancy).
Subjects who are randomized for IUD insertion at their post puerperal visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
For women randomized for IUD insertion at their postpartum visit (n=33) the following will be done:(n=33):
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton full term pregnancy at ≥37 weeks gestation confirmed by LMP and first trimesteric ultrasound.
- •Desired copper IUD placement for postpartum contraception.
- •Candidate for cesarean delivery.
- •Regional anesthesia.
排除标准
- •Anatomic uterine abnormalities distorting the uterine cavity (obstructive myomata, bicornuate, septate, etc)
- •Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
- •Puerperal sepsis.
- •Unresolved postpartum hemorrhage.
- •Known or suspected untreated endocervical gonorrhea, chlamydia.
- •Wilson's disease, copper allergy (Paragard only).
- •Known or suspected cervical or endometrial cancer or pelvic tuberculosis.
- •Prolonged procedure > 2 hours.
- •Preoperative hemoglobin 9.5 gm/dl.
结局指标
主要结局
IUD expulsion rate
时间窗: 6 months (following the insertion)
to measure the frequency of IUD expulsion (IUD not found in ultrasound) following insertion by ultrasound examination.
次要结局
- Missed threads rate (threads not seen by speculum examination)(6 months (following the insertion))
- displaced IUD rate(6 months (following the insertion))
- pregnancy rate(within the 1st 6 months after insertion)
- satisfaction rate(6 months after insertion)
研究者
Moutaz Sherbini
Assistant Professor
Cairo University
