Clinical trial NCT05383924: Intrauterine Contraceptive Device Insertion During Cesarean Section (CS) Versus Delayed Insertion
Official title: Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
IUD
Keywords: IUD
immediate postplacental IUD
interval IUD insertion
compliance
expulsion
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study aims to compare immediate postplacental IUD insertion versus delayed insertion as regards patient's compliance in women undergoing planned cesarean section. One group will have the IUD inserted during cesarean section. Another group will undergo IUD insertion after 6 weeks of delivery by CS.
Primary purpose: PREVENTION

Brief summary: After ethical committee approval and written consent from the patients, this prospective quasi-randomized controlled clinical trial was performed on pregnant women planning to deliver by cesarean section and willing to participate in the study to investigate the value of immediate post placental IUD insertion versus delayed insertion on patient's compliance in Ain Shams University Maternity Hospital (ASUMH).

Detailed description: * After protocol approval by the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University; pregnant woman planning to undergo elective cesarean section in ASUMH were recruited from the antenatal clinic.
* Counselling was done about different postpartum contraceptive methods including immediate PPIUD and delayed IUD insertion.
* An informed written consent was taken from all participants before enrollment in the study and after explaining the purpose, possible risks and complications.
* History taking, examination, and investigations (CBC, follow-up Ultrasound) were done to identify eligible patients according to the inclusion and exclusion criteria.
* Randomization: Eligible patients were quasi-randomized into 2 groups:

Group (A) (PPIUD group): immediate postplacental IUD insertion. Group (B) (delayed insertion group): delayed IUD insertion at the 6th week postpartum visit.

Randomization was done through "Alternation" method.

- Allocation: the first patient (no.1) was allocated to group (A) and second patient (no.2) to group (B) and so on by ''Alternation method '' till fulfilling the sample size.

Procedure:

Type of IUD: Model T-shaped Copper 380 A: Safe-load® or Pregna®

* Group A (PPIUD group): cesarean section (CS) was performed by experts in post-placental IUD insertion as follows: The IUD was inserted after removal of the placenta and after the uterus had become hemostatic. After initiating closure of the uterine incision, the IUD was placed at the top of uterine fundus manually. Before closing the uterine incision, the strings were placed gently in the lower uterine segment manually. After this was accomplished, the uterine incision closure could be completed. The strings usually descended spontaneously through the cervix during the puerperal period. If the cervix was closed, it would be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this was done, the surgeon would recheck to make sure IUD remains at the fundus of the uterus prior to closing the uterine incision. Strings can be trimmed at a follow-up visit. Ultrasound was done after the CS to ensure proper placement of the IUD.
* Group B (control group) (delayed insertion group): cesarean section was done by expert supervisors, then contacts were taken to arrange for delayed IUD Insertion at the 6th week postpartum visit as follows: IUD was prepared prior to starting procedure. Vaginal speculum was placed then prepared vaginal wall with betadine. Tenaculum was applied at anterior cervical position then uterine sounding was performed. IUD was placed according to package insert, then the threads were cut 2-3 cm from cervical os. Ultrasound was done to ensure proper placement of the IUD.
* Follow-up: follow-up visits were conducted at 6, 12months post-insertion (questionnaire, ultrasound, hemoglobin level).

Eligibility criteria: Inclusion Criteria:

* Pregnant women planned for delivery by cesarean section in Ain Shams University Maternity hospital

Exclusion Criteria:

* Women not consenting to use IUD as a contraceptive method and preferring other methods.
* Any woman with condition included in Category 3 or 4 for Cu-IUD in medical eligibility criteria for contraceptive use World Health Organization (WHO) 2015
* Neuropsychiatric disorder causing altered mentality or perception
* Intrapartum complications as chorioamnionitis, massive blood loss, or hysterectomy.
* Anemic patients (hemoglobin level \<10g/dl).

Primary outcomes:
measure: Patient compliance
timeFrame: at 6 months after the procedure
measure: Patient compliance
timeFrame: at 12 months after the procedure
Secondary outcomes:
measure: Abnormal Bleeding pattern
timeFrame: at 12 months after the procedure
measure: dyspareunia
timeFrame: at 12months after the procedure
measure: Efficiency
timeFrame: at 6 months after the procedure
measure: Efficiency
timeFrame: at 12 months after the procedure
measure: Anemia
timeFrame: at 12months after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Faculty of Medicine Ain Shams University
name: Mohamed Sweed, MD
role: STUDY_CHAIR
References: