Clinical trial NCT05756998: New Method of IUD Insertion During Cesarian Section
Official title: New Method of IUD Insertion During Cesarian Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Contraception
Keywords: IUD
cesarian section
expulsion
postpartum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 156
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: In women undergoing elective CS, half of them will have Intra-caesarian copper T 380 IUD insertion using the standard method and the remaining half will undergo copper T 380 IUD insertion during CS using a new technique in order to detect which technique is more effective in having more accurate IUD position with visible threads.

Detailed description: Intrauterine device (IUD) is considered one of the most acceptable and effective contraceptive methods used. It is widely accepted and used in Egypt at a large scale than any other type of contraception with many advantages over the other types of contraceptive methods including long acting hormonal methods . Despite IUD complications, it remains the most accepted method, as it has many advantages like being non-coital related, had no systemic complications, of long duration and reversible with rapid return of fertility after its removal . The complications of IUD include heavy menstrual bleedings, menstrual irregularities and infection complications which could be minimized by using strict aseptic techniques during insertion . The most distressing complication is the displacement of IUD, especially if this displacement was extra-uterine, as the patient needs a surgical maneuver (endoscopic usually) for extraction of this IUD. Displacement of IUDs puts a financial and psychological burden to the patient also increases the risk of unwanted pregnancies and its related risks . Displacement of IUD occurs mainly during its insertion, and occurs mainly due to rough or wrong technique; also IUD insertion at a wrong timing may increase risk of IUD displacement. So it is very important to insert IUDs at the proper time with the proper technique . Timing of insertion of IUD after cesarean section is a matter of debate, some gynecologists insert IUDs during cesarean section after placental removal, while other gynecologists prefer insertion of IUDs after an interval either immediately after puerprium (42 days), or after 6 months post-cesarean section, but the majority inserts IUDs after 3 months from cesarean section . The idea of waiting a three-month interval after cesarean section is to assure that the scar had completely healed and the uterus involutes completely to its pre-pregnancy size. The drawbacks of waiting this long interval are poor accessibility of the cervix which may be pulled upward in some cases of repeated cesarean section and loss of self-enthusiasm for rapid contraception after delivery .

Eligibility criteria: Inclusion Criteria:

* pregnant , full term patients , scheduled for elective CS.

Exclusion Criteria:

* contraindications for IUD insertion ( chorioamnionitis , congenital uterine malformations ) - Patient refusing IUD contraception.
* Patients with intra-operative bleeding or vital instability.
* Active genital infection at time of insertion.
* Medical disorders e.g. : cardiac , bleeding disorders , T.B. .. etc.

Primary outcomes:
measure: accuracy of IUD position.
timeFrame: 3 months
measure: visibility of the threads of IUD.
timeFrame: 3 months
Secondary outcomes:
measure: complications of IUD
timeFrame: 1 month
measure: patient overall satisfaction about the new technique
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy outpatient infertility clinic
Study officials:
References:
citation: Cleland J, Ali M, Benova L, Daniele M. The promotion of intrauterine contraception in low- and middle-income countries: a narrative review. Contraception. 2017 Jun;95(6):519-528. doi: 10.1016/j.contraception.2017.03.009. Epub 2017 Mar 30.
citation: Goldstuck ND, Steyn PS. Insertion of intrauterine devices after cesarean section: a systematic review update. Int J Womens Health. 2017 Apr 18;9:205-212. doi: 10.2147/IJWH.S132391. eCollection 2017.
citation: Sunder, G. and Snigdha, G. (2016) Displaced Intrauterine Device: A Retrospective Study. The Journal of Medical Research, 2, 41-43.