DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial

Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraceptive Implant Utilization; Lactation

Intervention: Jadelle (Device); Jadelle (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, San Francisco

Official(s) and/or principal investigator(s):
Sarah Averbach, MD, Principal Investigator, Affiliation: University of California, San Francisco
Jody Steinauer, MD, MAS, Principal Investigator, Affiliation: University of California, San Francisco
Josephat Byamugisha, MBChB, PhD, Principal Investigator, Affiliation: Mulago Hospital and Makerere University College of Health Sciences

Overall contact:
Sarah Averbach, MD, Phone: 415-206-3030, Email: Sarah.Averbach@ucsf.edu

Summary

This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG) contraceptive implant within 5 days of delivery improves implant utilization at 6 months postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.

Clinical Details

Official title: Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion).

Secondary outcome:

Breastfeeding continuation rates as measured by self-report over the initial 6 months.

Time to lactogenesis measured by self-reported onset of lactogenesis.

Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months.

Pregnancy

Detailed description: Waiting until 6 weeks postpartum to initiate contraception puts women at risk for unintended pregnancy and short birth intervals. Short birth intervals of less than 18 months are associated with an increased risk of preterm delivery and low birth weight infants. Subdermal implants are advantageous for the postpartum period because they are long-acting, reversible, and highly effective, and they do not contain estrogen or require intrauterine placement. In observational studies postpartum continuation rates have been shown to be greater than 95% after 6 months and 86-87% after 1 year in US populations. Implants are not routinely available during the immediate postpartum period in Uganda, and availability could improve the contraceptive method mix for postpartum women in that country. The results of this study may support increasing access to a form of immediate postpartum LARC (long acting reversible contraception) in a developing country. This is a randomized, controlled trial of the association between immediate postpartum contraceptive implant placement and implant utilization at 6 months postpartum among women in Uganda. This study will compare the proportion of women using the Levonorgestrel contraceptive implant at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6 weeks after delivery (delayed insertion). The study population is women who have a delivery at Mulago hospital in Kampala, Uganda and choose a contraceptive implant for postpartum contraception. The investigators plan to enroll 202 women who are planning to receive a postpartum Levonorgestrel contraceptive implant after delivery to find out whether the timing of postpartum administration of the implant (prior to hospital discharge or 6 weeks after delivery) affects implant utilization, satisfaction with the implant, vaginal bleeding or breastfeeding.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female

- 18 - 50 years old

- Voluntarily requesting contraceptive implants for postpartum contraception

- Vaginal delivery or cesarean delivery at Mulago Hospital

- Willing and able to give informed consent

- Agree to a possible home visit for follow up

- Access to a cellphone for the duration of the study

Exclusion Criteria:

- Current breast cancer or breast cancer within the past 5 years

- Decompensated cirrhosis or a liver tumor

- Unexplained vaginal bleeding prior to pregnancy

- Current (or planned) use of Efavirenz medication

Locations and Contacts

Sarah Averbach, MD, Phone: 415-206-3030, Email: Sarah.Averbach@ucsf.edu

Mulago Hospital, Kampala, Uganda; Recruiting
Othman Kakaire, MBChB, Phone: 256772580330
Josephat Byamugisha, MBChB, PhD, Principal Investigator
Additional Information

Starting date: January 2015
Last updated: July 26, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017