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Completed

NCT Number: NCT03492034

IUD Insertion During Cesarean Section

Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial

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Key information

Conditions

Contraception

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant woman aged between 18 to 40 years old.
  • Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
  • Body mass index between 19-30 kg/m2
  • Seeking contraception after delivery.

Exclusion criteria

  • History of menorrhagia or severe dysmenorrhea.
  • History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
  • Patients who have bleeding disorders.
  • Anemia (Hb < 9 g %).
  • Chronic depilating diseases reducing immunity such as Diabetes.
  • Structural uterine anomaly or large uterine fibroids distorting anatomy.
  • History of previous IUD expulsion or removal for complications.
  • Unexplained uterine bleeding.
  • Copper allergy or Wilson disease.
  • Gestational trophoblastic disease with persistently elevated Beta HCG.
  • Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
  • Complications during cesarean section e.g. postpartum hemorrhage.
  • Cesarean section during placenta previa.

Treatment and study plan

IUD during CS

Device

IUD insertion during CS

IUD after puerperium

Device

IUD after puerperium

Primary outcomes

  1. IUD expulsion rate

    Time frame: 6 weeks

Secondary outcomes

  1. Bleeding

    Time frame: 6 weeks

    number of pads changed per day

  2. Degree of Pain

    Time frame: 6 weeks

    Visual Analogue Scale from 1 to10 (0 being no pain and 10 maximum pain tolerated)

  3. dyspareunia

    Time frame: 6 weeks

    Visual Analogue Scale from 0 to10 (0 being no pain and 10 maximum pain tolerated)

  4. patient satisfaction

    Time frame: 6 weeks

    Visual Analogue Scale from 0 to10 (0 being maximum dis-satisfaction and 10 maximum satisfaction)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 10, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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