Ain Shams Maternity Hospital
Cairo, 11311, Egypt
Completed
NCT Number: NCT03404622
Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
The aim of current study is to compare the rates of IUCD expulsion and complications in immediate post-placental insertion versus delayed IUCD insertion (6-weeks after cesarean delivery)
Completed
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Notify MeKey information
Age range
18 year–45 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
About this study
Intrauterine devices (IUDs) are among the most effective forms of contraception, offering greater than 99% efficacy per year of use and are completely reversible .
Post-placental intrauterine device (IUD) insertion is a safe, convenient, and effective option for postpartum contraception. "Post-placental" refers to insertion within 10-15 minutes of placental delivery, after vaginal or cesarean delivery.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age: 18 -45
- Singleton pregnancy at ≥32 weeks gestation at time of enrollment
- Voluntarily requesting to IUD placement for postpartum contraception
- Able to give consent and agree to the terms of the study
Exclusion criteria
- Uterine anomaly that preventing replacement of IUD.
- Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
- Puerperal sepsis and unresolved postpartum hemorrhage.
- IUD allergy (copper).
- Systemic lupus erythematosus with severe thrombocytopenia
Treatment and study plan
IUCD
DrugIUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery
Primary outcomes
-
Expulsion
Time frame: 3 months
The time until expulsion of the IUD will be defined as the time from insertion until expulsion occurred, if known. If the date of expulsion is not known, this will be documented as the day after the IUD was last known to be in place. If a pregnancy is detected and the IUD is absent (and the participant was unaware of expulsion), the expulsion will be assumed to have occurred at the time of conception, as determined by gestational age on ultrasound. Expulsions will be measured as total expulsions and separately noted whether complete or partial
Secondary outcomes
-
Displacement
Time frame: 3 months
The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word
-
Infection
Time frame: 3 months
The diagnosis of PID will be made based on the 2006 CDC guidelines and the criteria used in the PEACH study.
-
Bleeding
Time frame: 3 months
Irregular bleeding (including spotting, light bleeding, heavy or longer menstrual period) are common in the first 3 months and may persist.
-
Perforation
Time frame: 3 months
The diagnosis of a perforation may be made by a transvaginal sonogram that shows no IUD within the uterus and an abdominal radiograph that show IUD within the abdominal cavity.
Sponsors and collaborators
Lead sponsor
ALshaimaa Aboalhassan Ali
Other
Registry information
Official study title
: Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2017
- First posted
- Jan 19, 2018
- Registry last updated
- Jan 29, 2018
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.