Adolescent PregnancyADPRENCT03360240
Blood Pressure in Adolescents With PReclampsia and Eclampsia.
An observational study of Adolescent Pregnancy and Preeclampsia and Eclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 8 sites in 6 countries.
Trial summary
Levels of blood pressure in adolescents with preeclampsia and eclampsia: Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two… Read more about this study
- Who is it for?
- Ages 12 to 19 years, women only
- Conditions the study is for
- Adolescent Pregnancy, Preeclampsia and Eclampsia
- How many people
- 1,050 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 1 Aug 2017to 8 Mar 2018
- How long will I take part?
- 11 Months
- 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 12 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Pregnant patients who are 19 years of age or younger and more than 23 weeks pregnant, where the cases are those that develop preeclampsia (mild), severe preclampsia, gestational hypertension and eclampsia; and the controls patients of the same age and with more than 23 weeks of pregnancy without hypertension.
Who may be able to join
- Criteria for inclusion cases: Patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of age. pregnancy. That you get the data of the termination of your pregnancy.
Who cannot join
- Patients with pregnancy that starts before 19 years of age that does NOT develop preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of pregnancy. That you get the data of the termination of your pregnancy.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Peru2 sites
Hospital Regional de Cajamarca
Cajamarca
Hospital Nacional Docente Madre Niño, San Bartolomé,
Lima
About this study
Official title: Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.
Levels of blood pressure in adolescents with preeclampsia and eclampsia:
Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia.
The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg.
The sample is 1050: (350 Cases and 700 Controls).
Read the detailed description
Levels of blood pressure in adolescents with preeclampsia and eclampsia: cases and controls study.
It is unknown whether the blood pressure levels used for the diagnosis of preeclampsia have the same impact in adolescents as in older women, however for the diagnosis of preeclampsia and severe hypertension the same criteria of hypertension are used regardless of age maternal.
It is necessary to do research to determine the values of blood pressure with which adolescents convulse and also to validate if slight increases in baseline blood pressure in adolescents are associated with prediction of preeclampsia and eclampsia.
Unfortunately, 85% of teenage pregnancies occur in non-industrialized countries such as those in Latin America, and it is estimated that 25% of maternal deaths occur in adolescents
Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. Controls are patients with the same criteria but WITHOUT hypertension during this pregnancy.
The statistical analyzes are based on comparing blood pressure levels between the two groups, in addition blood pressure levels like 30/15 on the systolic and diastolic basal levels will be created and compared between the two groups, especially when it is not possible to have 140 / 90 mm Hg.
- Conditions
- Adolescent Pregnancy, Preeclampsia and Eclampsia
- Medical subject headings
- Pre-Eclampsia, Eclampsia
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 |
|---|---|---|
| Cases | Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. | |
| controls | Are patients with pregnancy that starts before the age of 19 that without develops (preeclampsia mild), severe preeclampsia, gestational hypertension or eclampsia) that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of blood pressure
Level of blood pressure during pregnancy or delivery
Measured: after 24 weeks of gestactión to delivery.
Secondary outcomes (2)
severe hypertension
hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.
Measured: after 24 weeks of gestactión to delivery.
parity
number of previous birth
Measured: birth before actual pregancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Aug 2017
- Primary completion8 Mar 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent PregnancyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,050 participants (actual)
- Target duration
- 11 Months
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
- Investigators
- Paulino Vigil, Principal investigator, Complejo CSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360240
- Sponsor's protocol ID
- Latin Adolescents
- Acronym
- ADPRE
- Status last verified
- Sep 2018
- First submitted
- 28 Nov 2017
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.
- ClinicalTrials.gov ID
- NCT03360240
- Acronym / sponsor ID
- ADPRE / Latin Adolescents
- Conditions
- Adolescent Pregnancy, Preeclampsia and Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- Complejo Hospitalario Dr. Arnulfo Arias MadridUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 4 Dec 2017 (actual)
- 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.
Levels of blood pressure in adolescents with preeclampsia and eclampsia:
Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia.
The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg.
The sample is 1050: (350 Cases and 700 Controls).
Detailed description
Levels of blood pressure in adolescents with preeclampsia and eclampsia: cases and controls study.
It is unknown whether the blood pressure levels used for the diagnosis of preeclampsia have the same impact in adolescents as in older women, however for the diagnosis of preeclampsia and severe hypertension the same criteria of hypertension are used regardless of age maternal.
It is necessary to do research to determine the values of blood pressure with which adolescents convulse and also to validate if slight increases in baseline blood pressure in adolescents are associated with prediction of preeclampsia and eclampsia.
Unfortunately, 85% of teenage pregnancies occur in non-industrialized countries such as those in Latin America, and it is estimated that 25% of maternal deaths occur in adolescents
Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. Controls are patients with the same criteria but WITHOUT hypertension during this pregnancy.
The statistical analyzes are based on comparing blood pressure levels between the two groups, in addition blood pressure levels like 30/15 on the systolic and diastolic basal levels will be created and compared between the two groups, especially when it is not possible to have 140 / 90 mm Hg.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 11 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. |
| controls | – | –Are patients with pregnancy that starts before the age of 19 that without develops (preeclampsia mild), severe preeclampsia, gestational hypertension or eclampsia) that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant patients who are 19 years of age or younger and more than 23 weeks pregnant, where the cases are those that develop preeclampsia (mild), severe preclampsia, gestational hypertension and eclampsia; and the controls patients of the same age and with more than 23 weeks of pregnancy without hypertension.
Key inclusion criteria (1 listed)
- Criteria for inclusion cases: Patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of age. pregnancy. That you get the data of the termination of your pregnancy.
Key exclusion criteria (1 listed)
- Patients with pregnancy that starts before 19 years of age that does NOT develop preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of pregnancy. That you get the data of the termination of your pregnancy.
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
Levels of blood pressure
Time frame: after 24 weeks of gestactión to delivery.
Level of blood pressure during pregnancy or delivery
2 secondary outcomes
severe hypertension
Time frame: after 24 weeks of gestactión to delivery.
parity
Time frame: birth before actual pregancy
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 18 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Paulino Vigil principal investigator
Complejo CSS
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Pregnancy and Preeclampsia and Eclampsia, run by Complejo Hospitalario Dr. Arnulfo Arias Madrid at 8 sites in 6 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 1 inclusion and 1 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Panama, Peru, Bolivia, Colombia, Guatemala and 1 more country. 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?
Levels of blood pressure (time frame: after 24 weeks of gestactión to delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2018.