Ain Shams Maternity Hospital
Cairo, Egypt
NCT Number: NCT05383924
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).
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Not applicable
Cairo, Egypt
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.
Procedure:
Type of IUD: Model T-shaped Copper 380 A: Safe-load® or Pregna®
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: at 6 months after the procedure
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
Time frame: at 12 months after the procedure
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
Time frame: at 12 months after the procedure
heavy menstrual bleeding or other abnormal uterine bleeding as reported by history taking
Time frame: at 12months after the procedure
pain during intercourse, as reported by history taking
Time frame: at 6 months after the procedure
successful insertion and proper position of the IUD, as confirmed by ultrasound imaging
Time frame: at 12 months after the procedure
proper position of the IUD, as confirmed by ultrasound imaging
Time frame: at 12months after the procedure
hemoglobin drop by follow-up of hemoglobin level after the procedure
Ain Shams Maternity Hospital
Other
Patient's Compliance to Intrauterine Device: Immediate Postplacental Insertion Versus Delayed Insertion in Women Undergoing Planned Cesarean Section
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02076217
Birth Control, Contraception
West Valley City, Utah, United States
View Trial DetailsNCT06042556
Contraception, IUD
Renton, Washington, United States
View Trial DetailsNCT04379102
Contraception, IUD
Istanbul, İ̇stanbul, Turkey (Türkiye)
View Trial DetailsNCT01185678
Behavior, Contraception
Many Locations, Poland
View Trial Details