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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).
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®
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postplacental IUD (PP-IUD) insertion | Active Comparator | patients will have immediate postplacental IUD insertion |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Sweed, MD | Faculty of Medicine Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams Maternity Hospital | Cairo | Egypt |
upon reasonable request to the principal investigator, individual participant data can be shared
individual participant data with supporting information will be available after study completion for 6 months after publication
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
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
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masking is not applicable
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| 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. |
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| 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 |