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临床试验/NCT06806358
NCT06806358已完成不适用

Clinical and Ultrasonographic Predictors of IUD Related Complications: A Prospective Cohort Study

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Failed IUD insertion

研究概览

简要总结

  • All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.
  • All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.

Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)

详细描述

All patients fulfilling the selection criteria undergo complete clinical examination and detailed medical history obtained. Each patient had a Case Record Form (CRF) recording participants' name. number, previous deliveries and abortions, age, height, weight, BMI, LMP, past medical and surgical history and contraceptive history.

- All participants will be subjected to transvaginal ultrasound to measure uterine size, endometrial and myometrial thickness, uterine position, cervical length, cervical diameter and for detection of any contraindications for IUD insertion.

Power Doppler Energy (PDE) measurement for subendometrial microvascularization will be done and categorized as women with minor subendometrial vascularization (Classifications I and II) and major subendometrial vascularization (Classifications III, IV and V)

Only clinicians with proven proficiency in IUD insertion will be allowed to perform insertions.

  • Perform a bimanual examination to determine the size, shape, and position of the uterus.
  • Insert a warm, moistened speculum.
  • Cleanse the cervix with an antiseptic solution.
  • Open the sterile insertion instruments without touching the inside of the packet and place within easy reach.
  • Remove the tenaculum by its handle and grasp the anterior or posterior lip of the cervix. Close gently to the first notch. Having the woman to cough while the tenaculum is being attached can ease the pinch.
  • Apply gentle traction with the tenaculum to straighten the canal.
  • Remove the sound by its handle and gently insert it to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.
  • Open the IUD pack without touching its contents.
  • Put on sterile gloves.
  • Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.
  • Gently remove the tenaculum. Tamponade any bleeding from the tenaculum site until it is resolved.
  • Trim the strings of the IUD to 3-4 cm in length and note the string length. Avoid cutting the strings too short. If the client or her partner becomes aware of the threads, they may be cut shorter in length at the follow-up visit.
  • Remove the speculum and assess the woman.
  • Pain score will be assessed using Visual Analogue Scale:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 41 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Age 20 -41 years
  • •BMI 18-25 kg/m2
  • •Women with any parity seeking contraception and choosing IUD as their preferred method after proper and thorough counseling
  • •Regularly menstruating women (duration of menstruation 3-7 days and length of cycle 22- 35 days).
  • •Not using any hormonal therapy or anticoagulation

排除标准

  • •Cervical abnormalities.
  • •Pregnancy or suspicion of pregnancy
  • •Congenital or acquired uterine anomalies which distort the uterine cavity (fibroids, endometrial polyps, cervical stenosis, bicornuate uterus, hypoplastic uterus < 6 cm)
  • •Acute PID or a history of PID within the past 3 months
  • •Postpartum or post-abortion endometritis within the past 3 months
  • •Current STI or within the past 3 months (including cervicitis)
  • •Cervical cancer
  • •Endometrial cancer
  • •Malignant gestational trophoblastic disease
  • •Undiagnosed vaginal bleeding
  • •Hypersensitivity to any component in the IUD (copper)
  • •Less than 6 weeks postpartum.
  • •Neurological or psychological conditions that may affect pain sensation

研究组 & 干预措施

IUD insertion

Experimental

IUD insertion in women needing contraception

干预措施: IUD insertion (Device)

结局指标

主要结局

Failed IUD insertion

时间窗: 9 months

failure of IUD insertion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed M Maged, MD

professor

Cairo University

研究点 (1)

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