Trial Outcomes & Findings for Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women (NCT NCT04005391)

NCT ID: NCT04005391

Last Updated: 2021-07-02

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 208 participants
• Primary outcome timeframe: Three months
• Results posted on: 2021-07-02

Participant Flow

Participant milestones

Measure	Postpartum Contraceptives Offered to Intervention Clusters Participants were offered postpartum contraceptives (condoms, pills, injection, implant)	Routine Care Offered to Control Clusters Participants received routine counseling on postpartum contraception but did not have access to drugs and devices
Overall Study STARTED	108	100
Overall Study COMPLETED	101	100
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women

Baseline characteristics by cohort

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=108 Participants Women will have postpartum contraceptive options (condoms "vive amor", birth control pills "segura plus", injectable "cyclofem", contraceptive implant "jadelle") offered to them at their routine forty day postpartum visit after routine care is provided, first. Offer of Participant's Choice of Contraception Method: Women will be offered a range of contraceptive options (condoms, contraceptive pills, medroxyprogesterone acetate injection, levonorgestrel implant) to choose from; they can decline to start a contraceptive method	Routine Care Offered to Control Clusters n=100 Participants Women will receive routine postpartum care	Total n=208 Participants Total of all reporting groups
Age, Continuous	21.9 years n=5 Participants	21.8 years n=7 Participants	21.8 years n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants	100 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	108 Participants n=5 Participants	100 Participants n=7 Participants	208 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	108 Participants n=5 Participants	100 Participants n=7 Participants	208 Participants n=5 Participants

PRIMARY outcome

Timeframe: Three months

Outcome measures

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=101 Participants offered pills, condoms, injectable, implant	Routine Care Offered to Control Clusters n=100 Participants given contraceptive counseling
Number of Participants With Implant Use at Three Months	28 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 Months

Participants actively using any contraceptive method three months after enrollment in the study as assessed by the three-month survey

Outcome measures

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=101 Participants offered pills, condoms, injectable, implant	Routine Care Offered to Control Clusters n=100 Participants given contraceptive counseling
Number of Participants With Any Contraceptive Use at Three Months	83 Participants	56 Participants

SECONDARY outcome

Timeframe: 12 Months

Participant satisfaction with any contraceptive method the woman might be using as determined by a survey question that asks if the woman is very satisfied, satisfied, dissatisfied, or very dissatisfied.

Outcome measures

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=94 Participants offered pills, condoms, injectable, implant	Routine Care Offered to Control Clusters n=91 Participants given contraceptive counseling
Contraceptive Satisfaction at Twelve Months "Very Satisfied" or "Satisfied"	68 Participants	57 Participants
Contraceptive Satisfaction at Twelve Months "Dissatisfied" or "Very Dissatisfied"	26 Participants	34 Participants

SECONDARY outcome

Timeframe: 12 Months

Continuation of any contraceptive method a woman started in the postpartum period assessed by a survey at three and twelve months after study enrollment

Outcome measures

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=94 Participants offered pills, condoms, injectable, implant	Routine Care Offered to Control Clusters n=91 Participants given contraceptive counseling
Number of Participants With Contraceptive Continuation at Twelve Months	73 Participants	59 Participants

SECONDARY outcome

Timeframe: 12 Months

Repeat pregnancy after enrollment in the study, as assessed at the enrollment (baseline) visit and at three and twelve months after study enrollment.

Outcome measures

Measure	Postpartum Contraceptives Offered to Intervention Clusters n=94 Participants offered pills, condoms, injectable, implant	Routine Care Offered to Control Clusters n=91 Participants given contraceptive counseling
Number of Participants With Repeat Pregnancy at Twelve Months	0 Participants	4 Participants

Adverse Events

Postpartum Contraceptives Offered to Intervention Clusters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Routine Care Offered to Control Clusters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margo Harrison

University of Colorado

Phone: 19176555178

Email: margo.harrison@cuanschutz.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place