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Intra-cesarean Post Placental Introducer Withdrawal IUD Insertion Technique

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05788354
Acronym
IUD
Enrollment
788
Registered
2023-03-28
Start date
2020-09-01
Completion date
2022-04-22
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Contraceptive Device Complication

Brief summary

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

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.

Interventions

placement of IUD during cesarean section after placental delivery

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Intrauterine displacement of the IUD6 monthstransvaginal ultrasound : the distance from the top of the uterine cavity to the IUD which should be \< 3 mm

Secondary

MeasureTime frameDescription
Missed or non-visualization of IUD threads6 monthsvaginal speculum examination: Missed or non-visualization of IUD threads by vaginal speculum examination
Discontinuation of the method6 monthsquestionnaire
duration of surgery6 monthstime of surgery in minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026