Pregnancy RelatedEMBRACENCT01209754
EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)
An observational study of Pregnancy Related, run by Microbicide Trials Network at 17 sites in 4 countries.
Trial summary
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 873 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 1 Oct 2009to 6 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will consist of female participants who become or became pregnant during HIV prevention agent trials, or who have or had planned exposures in pregnancy safety studies, and the infants resulting from those pregnancies. Mother participants must still be pregnant, or have had a pregnancy outcome diagnosis less than one year before screening/enrollment, and infant participants must be less than one year old. The study may include HIV-uninfected and -infected participants. Mothers may participate in EMBRACE without participation of their infants; however, infants whose mothers have not enrolled in EMBRACE will not participate.
Who may be able to join
- Able and willing to provide written informed consent to take part in the study
- During participation in a parent protocol, has/had a known confirmed pregnancy, meeting at least one of the following sets of criteria in A or B:
- Two consecutive monthly study visits, at least 14 days apart, with positive pregnancy tests, in the absence of signs/symptoms of miscarriage or participant report of pregnancy termination.
- One or more of the following assessments:
- Auscultation of fetal heart tones
- Positive pregnancy test confirmed by clinic staff in the presence of clinically confirmed enlarged uterus
Show all 13Show fewer
- Positive pregnancy test confirmed by clinic staff in the presence of missed menses (no menses occurring at least 60 days from the first day of the last menses) by participant report (For amenorrheic or irregularly cycling women, two consecutive positive hCG tests (criterion A) or any of the other clinical signs of pregnancy included under the criteria B listing will be used to confirm MTN-016 eligibility).
- Clinical assessment of fetal movement
- Demonstration of pregnancy by ultrasound
- Able and willing to provide adequate locator information, as defined in site SOPs
- Note: Participants do not have to be currently enrolled or engaged in follow-up in a parent protocol to participate in EMBRACE.
- Has written informed consent provided by parent(s)/guardian to take part in the study in a manner consistent with local standards, site Institutional Review Board (IRB) guidance and the US Code of Federal Regulations (CFR)
- Born to EMBRACE participant mother from pregnancy concurrent with participation in parent study
Who cannot join
- Has any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
- Pregnancy outcome occurred greater than one year ago
- Has any condition that, in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
- Has reached 1 year birth date
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
South Africa11 sites
CAPRISA eThekwini
Durban, KwaZulu-Natal, 4001
South African MRC HIV CTU Med Research Council; Botha's Hill Clinical Research Site
Durban
South African MRC HIV CTU Med Research Council; Isipingo
Durban
South African MRC HIV CTU Med Research Council; Overport
Durban
South African MRC HIV CTU Med Research Council; R.K. Khan Hospital
Durban
South African MRC HIV CTU Med Research Council; Tongaat
Durban
South African MRC HIV CTU Med Research Council; Umkomaas
Durban
South African MRC HIV CTU Med Research Council; Verulam
Durban
Wits Reproductive Health Institute (WRHI)
Johannesburg, Gauteng, 2001
CAPRISA-The Aurum Institute
Johannesburg, Guateng, 2193
Perinatal HIV Research Unit (PHRU)
Johannesburg, Soweto, 1804
Zimbabwe3 sites
UZ-UCSF HIV Prevention Trials Unit
Chitungwiza, Seke South
UZ-UCSF HIV Prevention Trials Unit
Chitungwiza, Zengeza
UZ-UCSF HIV Prevention Trials Unit
Harare, Spilhaus
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Uganda1 site
Makerere University-Johns Hopkins University Collaboration
Kampala
About this study
Official title: HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. The study population will consist of female participants who are identified as becoming pregnant during their participation in a microbicide or PrEP trial, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.
Read the detailed description
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort study of maternal exposures to investigational HIV prevention agents. Approximately 550 pregnant participants and 400 live infants will be offered enrollment. The study population will consist of current or recent female participants identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies. This study will also include infants resulting from those pregnancies. This protocol will monitor for adverse pregnancy and delivery outcomes, monitor the prevalence of major malformations, evaluate growth parameters of infants during the first year of life, and evaluate the prevalence and persistence of HIV drug resistance mutations in a cohort of infants who were either exposed to active study agents or not exposed to active study agents while in utero.
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Chemoprophylactic Exposure, Mother, Infant, malformations, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Women | Pregnant women exposed to an HIV prevention study agent during pregnancy | |
| Infant | Infants resulting from pregnancies where there exists maternal HIV prevention agent exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy and delivery outcomes comparison
To compare adverse pregnancy and delivery outcomes between participant mothers assigned to an active agent with those of mothers assigned to placebo/control. Pregnancy and delivery outcomes of interest are:
- delivery prior to 37 completed weeks of gestation
- stillbirth or intrauterine fetal demise (≥ 20 weeks)
- spontaneous abortion (< 20 weeks)
- ectopic pregnancy
- intrapartum hemorrhage
- postpartum hemorrhage
- non-reassuring fetal status
- chorioamnionitis
- hypertensive disorders of pregnancy
- gestational diabetes
- intrauterine growth restriction
Measured: Duration of Study
Major malformations comparison
To compare the prevalence of major malformations identified in the first year of life between infants of mothers assigned to an active agent with those of infants of mothers assigned to placebo/control. Major malformations are defined as structural abnormalities with surgical, medical, or cosmetic importance.
Measured: Duration of Study
Secondary outcomes (2)
Infant growth parameters comparison
To compare growth parameters in the first year of life between infants of mothers assigned to an active agent with those of mothers assigned to placebo/control. Growth parameters of interest are weight, length, and head circumference at birth, one month, six months and 12 months.
Measured: Duration of Study
HIV drug resistance mutations comparison
- To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants.
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study start1 Oct 2009
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbicide Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Richard Beigi, MD, Study chair, Microbicide Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209754
- Sponsor's protocol ID
- MTN-016
- Other IDs
- 3UM1AI068633, 10737
- Acronym
- EMBRACE
- Status last verified
- Jun 2021
- First submitted
- 23 Sep 2010
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Makanani B, Balkus JE, Jiao Y, Noguchi LM, Palanee-Phillips T, Mbilizi Y, Moodley J, Kintu K, Reddy K, Kabwigu S, Jeenariain N, Harkoo I, Mgodi N, Piper J, Rees H, Scheckter R, Beigi R, Baeten JM. Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy. J Acquir Immune Defic Syndr. 2018 Dec 15;79(5):566-572. doi: 10.1097/QAI.0000000000001861.
PubMed 30383589Mhlanga FG, Noguchi L, Balkus JE, Kabwigu S, Scheckter R, Piper J, Watts H, O'Rourke C, Torjesen K, Brown ER, Hillier SL, Beigi R. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials. 2018 Feb;19(1):8-14. doi: 10.1080/15284336.2017.1411419. Epub 2017 Dec 21.
PubMed 29268654
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study
- ClinicalTrials.gov ID
- NCT01209754
- Acronym / sponsor ID
- EMBRACE / MTN-016
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Chemoprophylactic Exposure, Mother, Infant, malformations, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- Microbicide Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 27 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. The study population will consist of female participants who are identified as becoming pregnant during their participation in a microbicide or PrEP trial, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.
Detailed description
The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort study of maternal exposures to investigational HIV prevention agents. Approximately 550 pregnant participants and 400 live infants will be offered enrollment. The study population will consist of current or recent female participants identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies. This study will also include infants resulting from those pregnancies. This protocol will monitor for adverse pregnancy and delivery outcomes, monitor the prevalence of major malformations, evaluate growth parameters of infants during the first year of life, and evaluate the prevalence and persistence of HIV drug resistance mutations in a cohort of infants who were either exposed to active study agents or not exposed to active study agents while in utero.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Women | – | –Pregnant women exposed to an HIV prevention study agent during pregnancy |
| Infant | – | –Infants resulting from pregnancies where there exists maternal HIV prevention agent exposure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of female participants who become or became pregnant during HIV prevention agent trials, or who have or had planned exposures in pregnancy safety studies, and the infants resulting from those pregnancies. Mother participants must still be pregnant, or have had a pregnancy outcome diagnosis less than one year before screening/enrollment, and infant participants must be less than one year old. The study may include HIV-uninfected and -infected participants. Mothers may participate in EMBRACE without participation of their infants; however, infants whose mothers have not enrolled in EMBRACE will not participate.
Key inclusion criteria (13 listed)
- Able and willing to provide written informed consent to take part in the study
- During participation in a parent protocol, has/had a known confirmed pregnancy, meeting at least one of the following sets of criteria in A or B:
- Able and willing to provide adequate locator information, as defined in site SOPs
- Note: Participants do not have to be currently enrolled or engaged in follow-up in a parent protocol to participate in EMBRACE.
- Has written informed consent provided by parent(s)/guardian to take part in the study in a manner consistent with local standards, site Institutional Review Board (IRB) guidance and the US Code of Federal Regulations (CFR)
Key exclusion criteria (4 listed)
- Has any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
- Pregnancy outcome occurred greater than one year ago
- Has any condition that, in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
- Has reached 1 year birth date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy and delivery outcomes comparison
Time frame: Duration of Study
To compare adverse pregnancy and delivery outcomes between participant mothers assigned to an active agent with those of mothers assigned to placebo/control. Pregnancy and delivery outcomes of interest are: * delivery prior to 37 completed weeks of gestation * stillbirth or intrauterine fetal demise (≥ 20 weeks) * spontaneous abortion (< 20 weeks) * ectopic pregnancy * intrapartum hemorrhage * postpartum hemorrhage * non-reassuring fetal status * chorioamnionitis * hypertensive disorders of pregnancy * gestational diabetes * intrauterine growth restriction
Major malformations comparison
Time frame: Duration of Study
To compare the prevalence of major malformations identified in the first year of life between infants of mothers assigned to an active agent with those of infants of mothers assigned to placebo/control. Major malformations are defined as structural abnormalities with surgical, medical, or cosmetic importance.
2 secondary outcomes
Infant growth parameters comparison
Time frame: Duration of Study
HIV drug resistance mutations comparison
Time frame: Duration of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Results publication: PubMed 30383589Makanani B, Balkus JE, Jiao Y, Noguchi LM, Palanee-Phillips T, Mbilizi Y, Moodley J, Kintu K, Reddy K, Kabwigu S, Jeenariain N, Harkoo I, Mgodi N, Piper J, Rees H, Scheckter R, Beigi R, Baeten JM. Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy. J Acquir Immune Defic Syndr. 2018 Dec 15;79(5):566-572. doi: 10.1097/QAI.0000000000001861.
- Results publication: PubMed 29268654Mhlanga FG, Noguchi L, Balkus JE, Kabwigu S, Scheckter R, Piper J, Watts H, O'Rourke C, Torjesen K, Brown ER, Hillier SL, Beigi R. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials. 2018 Feb;19(1):8-14. doi: 10.1080/15284336.2017.1411419. Epub 2017 Dec 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Beigi, MD study chair
Microbicide Trials Network
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by Microbicide Trials Network at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Africa, Zimbabwe, United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy and delivery outcomes comparison (time frame: Duration of Study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01209754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.