Clinical trial NCT06023849: Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
Official title: Trans Caesarean Intra Uterine Contraceptive Device Insertion Versus Conventional Postpartum 6 Weeks Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IUD
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: 1-Patient satisfaction and complication.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicin
Study officials:
References:
citation: Hem E, Bordahl PE. Max Sanger - father of the modern caesarean section. Gynecol Obstet Invest. 2003;55(3):127-9. doi: 10.1159/000071524.