Intrauterine Contraceptive Device Insertion During Cesarean Section (CS) Versus Delayed Insertion
Condition: Contraception; IUD
Study type: Interventional

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).
    

Intervention name(s): postplacental IUD insertion; delayed IUD insertion
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will have immediate postplacental IUD insertion as follows: The IUD is inserted after removal of the placenta and after the uterus has become hemostatic. After initiating closure of the uterine incision, the IUD is placed at the top of uterine fundus manually. Before closing the uterine incision, the strings are placed gently in the lower uterine segment manually. After this is accomplished, the uterine incision closure can be completed. The strings will usually descend spontaneously through the cervix during the puerperal period. If the cervix is closed, it'll be dilated from above with ring forceps. Strings can be passed through the cervix with ring forceps. If this is done, the surgeon will 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 will be done after the CS to ensure proper placement of the IUD.; cesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit as follows: Prepare IUD prior to starting procedure Place vaginal speculum then prepare vaginal wall with betadine Apply tenaculum at anterior cervical position then insert and remove uterine sound Place IUD according to package insert then cut threads 2-3 cm from cervical os. Ultrasound will be done to ensure proper placement of the IUD.
Other intervention name(s): immediate postplacental IUD insertion; interval IUD insertion
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IUD; immediate postplacental IUD; interval IUD insertion; compliance; expulsion