CClinicalTrials.gg
RecruitingNCT06023849IUDinsertionUpdated Sep 5, 2023

Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion

An interventional study of IUD insertion in IUD, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

To compare immediate post-placental intrauterine contraceptive device insertion versus conventional placement at 6 weeks interval (often referred to as delayed or interval insertion) as regard to:-

  1. Patient satisfaction.
  2. Expulsion rate.
  3. Complications
Read the detailed description

Until the 1960s, Intrauterine devices (IUCDs) and condoms were the only artificial methods for the control of fertility. Nowadays ,despite the presence of 12 contraceptive methods which include 9 modern methods (pill, IUD, injectable, implant, vaginal methods (diaphragm and contraceptive foam or jelly), male condom, female sterilization, male sterilization, and emergency contraception) and 3 traditional methods (periodic abstinence, withdrawal, and prolonged breastfeeding , the insertion of an IUCD still the second most prevalent method of family planning used worldwide (13.6%), after female sterilization (20.5%), among women of reproductive age who are married or cohabiting.

In Egypt, Egypt Demographic and Health Survey 2014 findings revealed that 59 percent of currently married women in Egypt are currently using a contraceptive method. The most widely used method is the IUD, followed by the pill and injectables. Thirty percent of currently married women are using the IUD, 16 percent are relying on the pill, and 9 percent are employing injectables. Relatively small proportions of women are using other modern methods, e.g., 1 percent reported currently using female sterilization. Two percent of women report use of traditional methods.

There are two ways used in IUD insertion, in the postpartum period or immediate post-placental IUD insertion, in which the insertion of IUD occurs within ten minutes after placenta delivery and after the puerperium (after puerperal or interval period). Intrauterine device insertion during cesarean section was first introduced in 1967 by Zerzavy by suturing the IUD to the posterior uterine fundus. Research in China and Belgium introduced post-placental IUD insertion technique during cesarean delivery with placed an IUD as high as possible in the fundus without suturing the fundus wall.

Intrauterine device insertion during early postpartum period is the most effective reversible contraceptive methods for many mothers because the contraception motivation is high, and it doesn't interfere with breast feeding. On the other hand, without an effective contraception in the first six weeks, woman may be accidentally pregnant. Hence, the mother prefers to insert IUD during cesarean delivery.

As cesarean section (CS) rates are rising in all countries, IUD insertion at the time of CS creates an opportunity to increase access to long-acting reversible contraception methods. Conversely, a previous CS scar may deter access to interval insertion of an IUD if a previous CS may result in difficulty with insertion and/or future IUD problems.

Inserting an IUD at the time of CS is a very attractive option; It adds very little time and cost to the procedure. The patient does not have to come back especially for follow-up, and there is no risk of primary perforation (secondary perforation is possible) as it is performed under direct vision.

02

Conditions studied

  • IUD
03

In context

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age: 18-40years.
  • Full term pregnancies delivered by cesarean section.
  • Desire to have intrauterine contraceptive device (Cu T) as a contraceptive option.
  • Agree to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Allergy to copper.
  • Ante- or intra-partum hemorrhage.
  • Ruptured of membranes for more than 18 h prior to delivery or Chorioamnionitis.
  • Known uterine abnormalities e.g., Bicornuate/septate Uterus, uterine myoma.
  • History of ectopic pregnancy.
  • Desire for pregnancy within 1 year of delivery.
  • Intrapartum fever >38 c.
  • Sever thrombocytopenia.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    PPIUD

    trans cesarean IUD insertion immediately post placental

    Device: IUD insertion

  • Active comparator
    interval

    IUD insertion 6 weeks interval post-partum

    Device: IUD insertion

Interventions

  • DeviceIUD insertion

    Trans Caesarean Intra Uterine Contraceptive Device Insertion and Conventional Postpartum 6 Weeks Insertion

06

What researchers measure

Primary outcomes

  1. 1-Patient satisfaction and complication.

    assessment of patient satisfaction using a questionnaire as follow: * Will you use the same method of contraception after the next delivery? * Will you recommend the same method to your fellows? * Are you happy or not with this procedure? give score from 1 to 10, 1 mean you are very unhappy while 10 mean you are very happy. * have you developed any complication?

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicin
    Assiut, Egypt
    Recruiting
08

References and documents

Publications

  • Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524. PubMed 12865589 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06023849
Lead sponsor
Al-Azhar University
Responsible party
Ahmed M.Osman (doctor, Al-Azhar University) — Principal investigator
First posted
Sep 5, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Aug 30, 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Sep 5, 2023

Study contacts

Ahmed osman, M.B.B.Ch
Contact
AhmedOsman.2244@azhar.edu.eg
01145883770
Selim Ahmed, Assistant Professor
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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