Intrauterine Contraceptive Device Insertion During Cesarean Section (CS) Versus Delayed Insertion

Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section

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).

Study Overview

• Status: Completed
• Conditions: Contraception; IUD
• Intervention / Treatment: Procedure: postplacental IUD insertion; Procedure: delayed IUD insertion

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).

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: postplacental IUD (PP-IUD) insertion; patients will have immediate postplacental IUD insertion	Procedure: postplacental IUD insertion; 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.; Other Names: immediate postplacental IUD insertion
ACTIVE_COMPARATOR: delayed IUD insertion; cesarean section will be done, then contacts will be taken to arrange for delayed IUD insertion at the 6th week postpartum visit	Procedure: delayed IUD insertion; 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 Names: interval IUD insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method? 1 = Yes 0 = No	at 6 months after the procedure
Patient compliance	compliance to IUD will be assessed by a user satisfaction questionnaire with scoring system: Q1, on a scale from 0 to 10, Are You satisfied of using Cu-IUD as a contraceptive method? (When 0 means "Not at all satisfied" and 10 means "Extremely Satisfied") 0 1 2 3 4 5 6 7 8 9 10 Q2, Will you continue to use Cu-IUD in future or reuse it after discontinuation? 1 = Yes 0 = No Q3, Do you recommend Cu-IUD for others to use it as a contraceptive method? 1 = Yes 0 = No	at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abnormal Bleeding pattern	heavy menstrual bleeding or other abnormal uterine bleeding as reported by history taking	at 12 months after the procedure
dyspareunia	pain during intercourse, as reported by history taking	at 12months after the procedure
Efficiency	successful insertion and proper position of the IUD, as confirmed by ultrasound imaging	at 6 months after the procedure
Efficiency	proper position of the IUD, as confirmed by ultrasound imaging	at 12 months after the procedure
Anemia	hemoglobin drop by follow-up of hemoglobin level after the procedure	at 12months after the procedure

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Chair: Mohamed Sweed, MD, Faculty of medicine ain shams university

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): June 5, 2022

Study Registration Dates

• First Submitted: May 14, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: compliance; IUD; immediate postplacental IUD; interval IUD insertion; expulsion
• Other Study ID Numbers: FMASU MS720/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon reasonable request to the principal investigator, individual participant data can be shared
• IPD Sharing Time Frame: individual participant data with supporting information will be available after study completion for 6 months after publication
• IPD Sharing Access Criteria: reasonable requests aiming for extending the benefit to more patients, or asking about the procedures done, will be assessed by the principal investigator and/or the study official, and shared either by contact e-mails or data repository when available
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No