Immediate Post-placental Insertion of IUCD During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion

• ClinicalTrials.gov Identifier: NCT03404622
• Recruitment Status: Completed
• First Posted: January 19, 2018
• Last Update Posted: January 29, 2018
• Sponsor: ALshaimaa Aboalhassan Ali
• Information provided by (Responsible Party): ALshaimaa Aboalhassan Ali, Ain Shams University

Study Description

Brief Summary:

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)

Condition or disease	Intervention/treatment	Phase
Mechanical Complication of Intrauterine Device	Drug: IUCD	Phase 1

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 200 pregnant women will be included in this study, will be divided into two groups Group 1 IUCD will be inserted immediate post-placental removal and include 100 pregnant women Group2 IUCD will be inserted 6 weeks postpartum and include 100 pregnant women.
• Masking: Double (Participant, Care Provider)
• Masking Description: Randomization will be based on the sequence generation created by computer and randomization tablets. Consenting patients fulfilling inclusion criteria will be randomizes into one of the following 2 groups. Randomized allocation will be kept in opaque sealed envelopes, with enrollment numbers written on the envelopes. the envelopes will contain a card on with the designated study group will be written. after enrollment of the patients in the study , the envelopes marked with study number will be unsealed and the patients allocated to either groups
• Primary Purpose: Health Services Research
• Official Title: : Immediate Post-placental Insertion of the Intrauterine Contraceptive Device During Cesarean Delivery Versus 6 Week Post-Cesarean Insertion
• Actual Study Start Date: September 20, 2016
• Actual Primary Completion Date: December 20, 2016
• Actual Study Completion Date: December 20, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Postplacental IUCD Insertion during Cesarean section; IUCD inserted postplacental removal	Drug: IUCD; IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery
Active Comparator: 6 Week Post-Cesarean Insertion of IUCD; IUCD inserted after six weeks post Cesarean section delivery	Drug: IUCD; IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Displacement [ Time Frame: 3 months ]
   The displacement is diagnosed by doing trans-vaginal ultrasound that showed IUCD that displaced up or down word
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: pregnant women
• Accepts Healthy Volunteers: Yes

Criteria

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:

1. Uterine anomaly that preventing replacement of IUD.
2. Chorioamnionitis (such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C).
3. Puerperal sepsis and unresolved postpartum hemorrhage.
4. IUD allergy (copper).
5. Systemic lupus erythematosus with severe thrombocytopenia

Contacts and Locations

Locations

Egypt

Ain Shams Maternity Hospital

Cairo, Egypt, 11311

Sponsors and Collaborators

ALshaimaa Aboalhassan Ali

Investigators

• Study Director: Yasser M Aboutalib, MD; Ain Shams University
• Study Director: Ahmed S AbdelHamid, MD; Ain Shams University
• Principal Investigator: ALshaimaa A Ali, MBBch; Ain Shams University
• Study Director: Haitham Torky, MD; Ain Shams University

More Information

• Responsible Party: ALshaimaa Aboalhassan Ali, physician, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03404622
• Other Study ID Numbers: shom
• First Posted: January 19, 2018
• Last Update Posted: January 29, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes