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

NCT05383924 | Completed DMC

• 1 other identifier: FMASU MS720/2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Contraception; IUD

Keywords

IUD; immediate postplacental IUD; interval IUD insertion; compliance; expulsion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Abnormal Bleeding pattern

  at 12 months after the procedure

• dyspareunia

  at 12months after the procedure

• Efficiency

  at 6 months after the procedure

• Efficiency

  at 12 months after the procedure

• Anemia

  at 12months after the procedure

Study Arms (2)

postplacental IUD (PP-IUD) insertion

ACTIVE COMPARATOR

patients will have immediate postplacental IUD insertion

Procedure: postplacental IUD insertion

delayed IUD insertion

ACTIVE COMPARATOR

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

Interventions

postplacental IUD insertion PROCEDURE

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.

Also known as: immediate postplacental IUD insertion

postplacental IUD (PP-IUD) insertion

delayed IUD insertion PROCEDURE

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.

Also known as: interval IUD insertion

delayed IUD insertion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mohamed Sweed, MD

  Faculty of Medicine Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: masking is not applicable
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 20, 2022
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 5, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: individual participant data with supporting information will be available after study completion for 6 months after publication
• 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

Locations

EG (1)