Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04005391 |
| Other study ID # |
17-1314 |
| Secondary ID |
5K12HD001271 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2018 |
| Est. completion date |
November 19, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Abstract
Background: Postpartum contraception is important to prevent unintended and closely spaced
pregnancies following childbirth.
Methods: This study is a cluster-randomized trial of communities in rural Guatemala where
women receive ante- and postnatal care through a community-based nursing program. When nurses
visit women for their postpartum visit in the intervention clusters, instead of providing
only routine care that includes postpartum contraceptive education and counseling, the nurses
will also bring a range of barrier, short-acting, and long-acting contraceptives that will be
offered and administered in the home setting, after routine clinical care is provided.
Discussion: A barrier to postpartum contraception is access to medications and devices. The
study removes some access barriers (distance, time, cost) by providing contraception in the
home. The community nurses were trained to place implants, which are a type of long-acting
reversible contraceptive method that was previously only available in the closest town, which
is about an hour away by vehicle. Therefore, the study examines how home-based delivery of
routinely available contraceptives and the less routinely available implant may be associated
with increased uptake of postpartum contraception within three months of childbirth. The
potential implications of this study include: nurses may be able to be trained to safely
provide contraceptives, including place implants, in the home setting, and provision of
home-based contraception may be an effective way of delivering an evidence-based intervention
for preventing unintended and closely spaced pregnancies in the postpartum period.
Description:
Background and Rationale: Postpartum contraception is important to prevent unintended and
closely spaced pregnancies following childbirth as well as to avoid future pregnancy in
mothers who have achieved their desired family size. Proper pregnancy spacing can prevent
maternal and perinatal morbidity and mortality. Globally, there is significant unmet need for
postpartum contraception.
Historically, in the community of interest, which is in the rural Southwest corner of
Guatemala bordering Mexico, a large majority (88%) of a convenience sample of women in the
community-based care program self-reported postpartum contraceptive use. However, 72% of
these women were using injectable contraceptives, which are considered short-acting, and are
less effective at preventing unintended and closely spaced pregnancies; the second most
common method was sterilization (21%). For the remaining women who did not seek sterilization
or injectable contraceptives, 0.5% of them reportedly used contraceptive pills, 0.5% condoms,
0.5% lactational amenorrhea, and 1.6% reportedly relied on natural family planning. Less than
4% of women were using long-acting reversible contraceptives (intrauterine devices or
implants), which are more effective at preventing unintended and closely spaced pregnancies
than injectables. The providers in the community had not been trained in implant and
intrauterine device placement, so the closest place to have a device placed was the most
proximate town to the communities, which is an hour away by vehicle. Additional barriers
discovered through qualitative research in the study communities found that barriers to
family planning use historically included knowledge, access to methods, fear of adverse
events, and a woman garnering her partner's approval. Community women's ideas for future
educational programming included teaching about how birth control methods work, how to talk
to partners about birth spacing, and myth debunking, and they requested the location and time
of teaching to occur at peripartum and pediatric visits.
Therefore, based on this preliminary data, the prospective research question is: if
community-based nurses are trained to place contraceptive implants, and they offer women
placement in the home at their postpartum visit (among other routinely available
contraceptive methods), will the ability to provide this service increase the uptake of
contraceptive implants in our communities of interest?
Specific Objectives or Hypotheses: The specific objective of the study is to observe in this
population where use of postpartum contraception is historically common among women, does
home delivery of the contraceptive implant increase utilization of the device above the
baseline rate of 3.2%. The investigators hypothesize, based on published data from other
settings, that if women receive proper counseling about all contraceptive methods, uptake of
long-acting reversible contraceptives, which in this study includes only the contraceptive
implant, is about 50%.
The secondary objectives are to observe if the home-based contraceptive delivery intervention
featured in this study is associated with overall increased contraceptive uptake,
continuation, and satisfaction in the intervention compared to the control clusters. The
hypothesis is that with increased uptake of the implant there will be longer continuation
rates and more satisfaction in the intervention clusters. The investigators also hypothesize
that increased contraceptive uptake, continuation, and satisfaction may be associated with
reduced short interval repeat pregnancy rates so the study also aims to survey participants
on their pregnancy status at enrollment, and three- and twelve-months after enrollment.
Trial Design: The protocol features an interventional, cluster-randomized, unmasked, parallel
group trial design. The eight study communities were randomized in a 1:1 allocation ratio to
either the intervention or control arms of the study, and the study is designed on a
superiority framework.
Study Setting: The study setting is in the home of women enrolled in the "Madres Sanas"
community-based nursing program offered by the Fundación para la Salud Integral de los
Guatemaltecos (FSIG). FSIG supports a community-based clinic called the Center for Human
Development in a region of Guatemala informally referred to as the Southwest Trifinio. This
region is at the intersection of the boundaries of three departments in Guatemala, and as
such no single Department takes responsibility for the health of the migrant workers that
reside there. The impoverished area has a population of around 25,000 people and experiences
poor pregnancy outcomes. This is why the University of Colorado Center for Global Health, in
partnership with AgroAmerica, built the Center for Human Development clinic and initiated the
community-based maternal and perinatal care programs, called Madres Sanas and Ninos Sanos,
respectively.
Madres Sanas is executed by teams of community nurses. The nurse teams are comprised of two
nurses, who are responsible for a segment of the communities in the region. There are ten
communities in the Madres Sanas program that were combined into eight clusters; our
biostastician did this in order to achieve similar cluster sizes, which was determined by the
number of births in the communities in 2017. Because our study enrolls women at their final
Madres Sanas visit, which is a postpartum visit that occurs about forty days out from
delivery, the cluster size was based on delivery volume of the communities. The nurse teams
are assigned by the nursing supervisor to their respective communities. They drive auto
rickshaws provided by the Center for Human Development out to the communities to conduct
their home visits, which include four antenatal visits and two postpartum visits. During the
visits the nurses both provide clinical care and collect quality improvement and research
data, and as such serve a dual function in their role. As noted, this study takes place at
the final Madres Sanas visit, which occurs forty days after delivery. Routine clinical care,
including postpartum contraceptive education, culminates at this time, although counseling on
postpartum contraception begins at the enrollment visit. After routine clinical care is
provided, the nurses offer enrollment in the study.
Interventions: All study activities and procedures begin at the forty-day postpartum visit,
which is the sixth and final scheduled visit of the Madres Sanas program. At this visit the
community nurses perform routine maternal and neonatal clinical care, which includes amongst
other activities, final counseling and education about postpartum contraception. In
intervention clusters, nurse teams bring a kit with them to the visit. After the visit they
describe the study and offer consent. Once a woman has discussed the risks, benefits, and
alternatives with her providers and determines she wishes to participate in the study, she
signs the consent form and the nurses offer her condoms, contraceptive pills, a
medroxyprogesterone contraceptive injection, or the levonorgestrel implant. The kit is
stocked with 10 condoms, one pack of pills, one syringe of medroxyprogesterone, and one
implant for each postpartum visit planned for that day. It also contains all the necessary
materials to place the implant or administer the injection under sterile conditions, such as
alcohol swabs and sterile gloves, etc.
All contraceptives are purchased using study funds and are sourced from a local provider of
contraceptive medications and devices. All contraceptives are routinely available and
approved for distribution in Guatemala. Because these are routinely available medications and
the study does not testing their effectiveness as contraceptives, there are no criteria for
discontinuing or modifying allocated interventions for a given trial participant such as
changing the drug dosing. Women are, however, screened for contraindications to the
contraceptive methods provided using the Medical Eligibility Criteria. The nurses have the
eligibility criteria chart in Spanish, laminated, and included in their kit for use during
study enrollment. As this is a pragmatic trial, there are no restrictions on care and
interventions that are permitted or prohibited during the trial. For example, if a
participant did not initiate a contraceptive method and wishes to, she can seek the method in
the community. Conversely, if she chose a method and opted for the implant but does not like
it, she is free to remove it at any time. The nurses will either remove it in the home
setting or advise the woman to present to the Center for Human Development where they can
remove it and potentially initiate a new method. The initial contraceptive provided in the
study setting is free, but any contraceptives sought or utilized after the study enrollment
visit is the woman's responsibility to locate and finance. Study contraceptives are only
provided in the home setting by the nurses at the enrollment visit and are not available or
offered at any subsequent visit.
Data Collection Methods: Quality improvement data from prior to study initiation was
collected from June 2017 - September 2018 by the Madres Sanas community nurses. This database
includes antepartum, intrapartum, and postpartum quality improvement data collected by the
community nurses during routine antenatal and postnatal care visits. The data is collected on
tablets and transmitted through the application REDCap. REDCap (Research Electronic Data
Capture) is a secure, HIPAA-compliant web-based application designed for data collection for
research studies. It provides an easy-to-use data entry system with data validation, the
ability to import data from external sources (Guatemala), automated exports to statistical
software, audit trails, branching logic and calculations, and sophisticated tool for building
and managing online surveys. As the community nurses have been using this software for years,
our study links to the Madres Sanas dataset, but involves separate forms in a separate REDCap
database. Just as the nurses prompt women during routine visits and collect general pregnancy
outcomes data for our quality improvement database, so will they use REDCap and the same
methods to collect enrollment and follow-up on participants and transmit the data to password
protected servers at the University of Colorado. There are cluster-specific REDCap forms that
are collected on enrollment, at three months, and at twelve months following enrollment.
Statistical Methods: To analyze our primary outcome the investigators are planning a
difference in differences analysis of the proportion of women actively using a contraceptive
implant three months after enrollment in intervention clusters as compared to control
clusters. The investigators plan to provide an unadjusted analysis and an adjusted analysis
for any cluster characteristics that are imbalanced between the two study arms. Once the
primary outcome is assessed, the investigators will likely use multivariate modeling to
determine characteristics of women, in each study arm, who used any postpartum contraception
within three months of delivery as compared to those who didn't, in both adjusted and
unadjusted analysis. The plan is to use descriptive statistics to compare the other secondary
outcomes between study arms (continuation and satisfaction). Finally, analysts will likely
perform survival analysis of time to repeat pregnancy by study arm to observe if there is any
statistically significant difference in the time to repeat pregnancy of women who became
pregnant by twelve months in the study groups. In summary, our analysis plans a difference in
differences analysis for our primary outcome, bivariate and multivariate analyses for our
secondary outcome of any contraception use by study arm, descriptive statistics for our
secondary outcomes of continuation and satisfaction rates among contraceptive users by study
arm, and a survival analysis for time to repeat pregnancy by study arm.
