Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

Study Overview
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Brief Summary
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This is a prospective randomized controlled study that was conducted to compare between the conventional (manual) technique of post placental IUD insertion and a new technique (intra-cesarean post placental introducer withdrawal IUD insertion technique) for IUD insertion during cesarean section regarding side effects and complications.

Detailed Description
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Complete history taking and clinical examination were obtained from all cases. Lower segment cesarean section though Pfannenstiel incision was performed. Copper T380 IUDs were inserted to all participants during cesarean section after delivery of the placenta using the following techniques: Group A (control group): (n = 420) First, the investigators Performed time out and verify that there were no contraindications to IUD placement:, Second, after package opening the investigators Removed the IUD from the introducer and trimmed IUD threads to 12 cm, Third, the investigators Grasped the IUD firmly along the stem of the device, Fourth the investigators Stabilized the uterus using the non-dominant hand or with the aid of an assistant and advanced the IUD through the hysterotomy to the fundus, Fifth, the investigators Removed hand and directed the IUD threads into the cervix and finally the investigators Closed the uterine incision, took care not to incorporate the IUD strings. Group B (study group): (n = 420) First the investigators Performed time out and verified that there were no contraindications to IUD placement, Second, after package opening the investigators Removed IUD from the introducer and trimmed the IUD threads to 12 cm and also trimmed the introducer to 12 cm, Third, the investigators Loaded the IUD again inside the introducer (through the trimmed end) and kept the arms of the IUD unfolded, Forth, the investigators removed the shoulders of the introducer, Fifth, the investigators held the uterus and stabilized it by the non-dominant hand and guided the introducer containing the IUD strings first through the cervix then the investigators advanced the introducer with the IUD arms unfolded to the fundus and kept the IUD their by pressing on the fundus, then the investigators pushed the introducer gently through the cervix to the vagina, Finally, the investigators Closed the uterine incision, took care not to incorporate the introducer or the threads and then the investigators removed the introducer gently manually from the vagina after closure of the skin and ceiling of the wound.

Official Title
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Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique: A New Standardized Technique for IUD Insertion During Cesarean Section. A Randomized Controlled Trial

Conditions
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Intrauterine Contraceptive Device Complication

Intervention / Treatment
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* Procedure: IUD insertion during cesarean section


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women attending for elective or emergency cesarean section Exclusion Criteria: upper segment cesarean scar cesarean for placenta previa or placenta accrete evident infections uterine anomalies uterine myomas bleeding tendency.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional method<br>IFirst, we Performed time out and verify that there were no contraindications to IUD placement:, Second, after package opening we Removed the IUD from the introducer and trimmed IUD threads to 12 cm, Third, we Grasped the IUD firmly along the stem of the device, Fourth we Stabilized the uterus using the non-dominant hand or with the aid of an assistant and advanced the IUD through the hysterotomy to the fundus, Fifth, we Removed hand and directed the IUD threads into the cervix and finally we Closed the uterine incision, took care not to incorporate the IUD strings. | Procedure: IUD insertion during cesarean section<br>* placement of IUD during cesarean section after placental delivery<br>|
| Experimental: new method<br>First we Performed time out and verified that there were no contraindications to IUD placement, Second, after package opening we Removed IUD from the introducer and trimmed the IUD threads to 12 cm and also trimmed the introducer to 12 cm, Third, we Loaded the IUD again inside the introducer (through the trimmed end) and kept the arms of the IUD unfolded, Forth, we removed the shoulders of the introducer, Fifth, we held the uterus and stabilized it by the non-dominant hand and guided the introducer containing the IUD strings first through the cervix then we advanced the introducer with the IUD arms unfolded to the fundus and kept the IUD their by pressing on the fundus, then we pushed the introducer gently through the cervix to the vagina, Finally, we Closed the uterine incision, took care not to incorporate the introducer or the threads and then we removed the introducer gently manually from the vagina after closure of the skin and ceiling of the wound. | Procedure: IUD insertion during cesarean section<br>* placement of IUD during cesarean section after placental delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrauterine displacement of the IUD | transvaginal ultrasound : the distance from the top of the uterine cavity to the IUD which should be < 3 mm | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed or non-visualization of IUD threads | vaginal speculum examination: Missed or non-visualization of IUD threads by vaginal speculum examination | 6 months | 
| Discontinuation of the method | questionnaire | 6 months | 
| duration of surgery | time of surgery in minutes | 6 months |