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Post-placental Intrauterine Device Insertion During Cesarean Section

A

Assiut University

Status

Completed

Conditions

Intrauterine Device Migration

Treatments

Procedure: Suture
Procedure: Intrauterine device insertion
Procedure: Cesarean section

Study type

Interventional

Funder types

Other

Identifiers

NCT03780985
IUD-Zahraa

Details and patient eligibility

About

Effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.The traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.Intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum Intrauterine device because it does not require a separate postpartum visit.

Advantage of post-placental Intrauterine device insertion, Intrauterine devices are recommended as first-line contraceptives by the American Academy of Pediatricians. The Centers for Disease Control and Prevention united state . Medical Eligibility Criteria for Contraceptive Use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of Intrauterine devices.

Enrollment

118 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age group : 18-40 years
  2. Women who will be willing to undergo elective cesarean section
  3. women desire using Copper IUD as long acting contraceptive method.

Exclusion criteria

  1. Intrauterine infection.
  2. Fundal Myoma.
  3. Hemorrhagic disorder
  4. Genital tract malignancy
  5. Uterine atony
  6. Sexually transmitted infection.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

118 participants in 2 patient groups

intrauterine device insertion with a suture fixation
Active Comparator group
Description:
Intruterine device through hysterotomy incision during cesarean section with a suture fixation
Treatment:
Procedure: Intrauterine device insertion
Procedure: Suture
Procedure: Cesarean section
intrauterine device insertion without a suture fixation
Active Comparator group
Description:
IUD through hysterotomy incision during cesarean section without a suture fixation
Treatment:
Procedure: Intrauterine device insertion
Procedure: Cesarean section

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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