Benefits of Use of 600 Microgram Misoprostol Vaginally Prior To Insertion Of An Intrauterine Device in Patients With Cesarean Scar: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methodology:
All patients were subjected to the following:
(i) Complete history taking (ii) Proper counseling: (iv) Examination: (v) 600ug misoprostol (3tablets Misotac®, ( Sigma Pharmaceutical Industries, Egypt )or placebo were administered Vaginally as deep as possible 6 hours before insertion of the IUD by gynecologist .
(vi) Insertion of IUD: (TCu-380A®,Pregna International Ltd, India ) After full history taken , Proper counseling, Informed consent is taken from each patients, examination ( general , abdominal and pelvic )to exclude any pathology .
A careful bimanual examination was done prior to IUD insertion. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.
The Next step was to sound and measure the depth of the uterus. The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward to straighten the angle of flection.
The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.
The outer sheath of the insert was withdrawn a short distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus .
The inserter tube was then removed. Then strings were cut to project about 2-4 cm from the external cervical os.
详细描述
Groups of study:
120 candidates for Cu T 380A IUD insertion were enrolled in the study. They were divided into two groups: Group 1: Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
Group 2: Sixty women received the placebo vaginally. The placebo and misoprostol were put in 120 numbered closed envelopes according to the table of random numbers and an envelope was allocated to each patient accordingly.
Methods of randomization:
To insure that everyone had an equal chance of participation, randomization was guided by table of random numbers using computer generated system(SPSS: windous version8) (SPSS Inc., Chicago, USA) double blinding technique was used thus; the investigator and the patient didn't know the group to which the patient was allocated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with previous cesarean section and with no previous vaginal delivery attending outpatient clinic for IUD insertion
排除标准
- •contraindications for misoprostol use (pregnancy and prostaglandin allergy).
- •contraindications for IUD use (gynecologic malignancy, pelvic inflammatory disease and unexplained vaginal bleeding).
- •previous vaginal delivery. And (4) medical disorders as diabetes, hypertension and bleeding tendency .
研究组 & 干预措施
Misoprostol group
Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
干预措施: Misoprostol (Drug)
Misoprostol group
Sixty women received 600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion.
干预措施: Intrauterine contraceptive device IUCD (Device)
placebo group
Sixty women received the placebo vaginally six hours before IUD insertion. Placebo is the same in size, color and shape to misoprostol.
干预措施: Intrauterine contraceptive device IUCD (Device)
结局指标
主要结局
Pain score
时间窗: At time of insertion
Pain scores were measured by Visual analogue scale (VAS) consists of 10 cm horizontal straight line with 2 ends At 0 end there was no pain and at 10 there was a severe pain
次要结局
- Difficulty of insertion of IUD in both groups(At time of insertion)
- side effects(from time of administration till insertion)
研究者
Ahmed Maged
Assistant professor
Cairo University