DengueCMFdengNCT04989673
Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana
An observational study of Dengue and Pregnancy Preterm, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
Symptomatic dengue virus infection in pregnant women could affect the mother, fetus and the newborn at birth. The risks of postpartum hemorrhage, prematurity and low birth weight are increased in dengue fever. Cases of vertical transmission have been described. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dengue, Pregnancy Preterm, Women
- What is being tested?
- Biological sampling and collection (serum), Biological sampling and collection (placenta) and Questionnaire
- How many people
- 628 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 11 Jul 2012to 11 Jul 2015
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women
Who may be able to join
- presenting a symptomatic dengue fever, confirmed biologically between the presumed date of conception (date determined after the first trimester dating ultrasound) and the date of delivery.
- Non inclusion Criteria:
- not presenting biologically confirmed dengue fever;
- with asymptomatic dengue fever between the presumed date of conception and the date of delivery.
- Unexposed group with fever (GNEF)
- presenting an infectious syndrome not due to the dengue virus between the presumed date of conception (date determined after the ultrasound dating of the first trimester) and the date of delivery.
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- Non inclusion Criteria:
- presenting with an infectious syndrome in the context of rubella (before 18 weeks), chickenpox, malaria, listeriosis, toxoplasmosis, primary HIV infection and CMV infection.
- Having neither fever (above 38.5 ° C for more than 48 hours) nor dengue confirmed biologically (symptomatic or not) since the beginning of pregnancy.
- Non inclusion criteria:
- Having presented a febrile syndrome (fever above 38.5 ° C for more than 48 hours) or dengue fever confirmed biologically (symptomatic or not) since the beginning of pregnancy.
Who cannot join
- Person included in the study with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery.
- Unexposed group without fever or dengue (GNES)
- People included in the study,
- with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery;
- having presented a febrile syndrome (fever above 38.5 ° C for more than 48 hours) between inclusion and childbirth.
Trial locations and contacts
1 site in 1 country.
About this study
Symptomatic dengue virus infection in pregnant women could affect the mother, fetus and the newborn at birth. The risks of postpartum hemorrhage, prematurity and low birth weight are increased in dengue fever. Cases of vertical transmission have been described. This study therefore proposes to quantify these risks in a pregnant woman presenting a clinical picture of dengue fever through a prospective, longitudinal and comparative study.
Read the detailed description
The main objective of the study is to compare the occurrence of prematurity between women who presented with symptomatic dengue fever and those who did not. However, febrile syndrome is known to be one of the main major risk factors for prematurity whatever its etiology (National College of French Gynecologists and Obstetricians CNGOF, High Authority of Health HAS). Dividing the unexposed group into 2 groups (group without fever or dengue GNES and group with fever not due to the dengue virus GNEF) is a means of observing on the one hand the effects of symptomatic dengue (the combination of effect of fever and the effect of the dengue virus) on the primary endpoint and on the other hand to observe the effects of fever in the context of another infectious pathology on the primary endpoint. This split also makes it easy to control the number of patient enrollments in each unexposed group.
This study protocol is only interested in investigating the impact of symptomatic dengue fever in pregnant women.
Primary objective: Compare the prematurity rate of the woman with symptomatic dengue fever (exposed group: GE) during her pregnancy compared to the woman who had neither fever nor infection with the dengue virus during her pregnancy (unexposed group without fever: GNES).
Secondary objectives:
- Describe the clinical pictures of symptomatic dengue fever in pregnant women;
- Compare the proportion of rates of prematurity, threat of premature delivery, spontaneous miscarriage, pre-eclampsia, eclampsia and delivery haemorrhage between the GE / GNES group and between the GE / GNEF group ( pregnant women who presented with dengue GE, those who had neither fever nor dengue during their pregnancy GNES and those who presented a fever not due to the dengue virus GNEF);
- Compare the proportion of MFIU and hypotrophy of newborns born to mothers between the GE / GNES group and between the GE / GNEF group;
- Describe the clinical and biological pictures of newborns at birth of mothers who presented with symptomatic dengue fever during their pregnancy (GE)
- Describe the morphological, biometric and velocimetric abnormalities of obstetric doppler ultrasounds of pregnant women who presented with dengue fever during their pregnancy (GE).
- Check for the presence of the dengue virus in the placenta of pregnant women who have had dengue fever during their pregnancy (GE).
- Constitute a direct biological collection (serums, placentas) used for the research of the dengue virus.
Epidemiological, etiological exposed-unexposed, multicentric, dynamic and contemporary with biological collection
- Conditions
- Dengue, Pregnancy Preterm, Women, Fever, Parturition; Precipitate, Infant, Newborn
- Being tested
- Biological sampling and collection (serum), Biological sampling and collection (placenta), Questionnaire, Data collection
- Keywords
- Symptomatic Dengue, Pregnancy Preterm, Vertical transmission, Fetus, French Guiana
- Medical subject headings
- Dengue, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sampling and collection (serum)Other
Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups
Biological sampling and collection (placenta)Other
Detection of dengue virus in the placenta of GE patients (additional tube of placenta)
QuestionnaireOther
Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).
Data collectionOther
Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).
| Study group | Role | What they receive |
|---|---|---|
| Exposed group (GE) | Pregnant women with symptomatic dengue fever, confirmed biologically between the presumed date of conception and the date of delivery. Receives: Other: Biological sampling and collection (serum); Other: Biological sampling and collection (placenta); Other: Questionnaire; Other: Data collection | |
| Unexposed group with fever (GNEF) | Pregnant women presenting a febrile syndrome not due to the dengue virus between the presumed date of conception and the date of delivery, excluding malaria, rubella, toxoplasmosis, chickenpox, listeriosis, CMV infection and primary HIV infection. Receives: Other: Biological sampling and collection (serum); Other: Questionnaire; Other: Data collection | |
| Unexposed group without fever or dengue (GNES) | Pregnant women exhibiting neither febrile syndrome nor asymptomatic dengue fever between the presumed date of conception and the date of delivery. Receives: Other: Biological sampling and collection (serum); Other: Questionnaire; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prematurity rate
The prematurity rate of each group will be assessed according to the WHO definition: a preterm birth is a birth occurring before the 37th week of amenorrhea and after the 22nd week of amenorrhea of a living fetus of at least equal weight at 500 g. This judgment criterion will be measured by the physician or midwife in charge of the patient, and reported on the RIG and the delivery book of the service. The date of delivery will be determined based on the 1st trimester dating ultrasound. The newborn will be examined by the midwife or pediatrician on the ward and weighed within half an hour after birth. A distinction will be made between medically induced premature delivery (reasons given) and spontaneous.
Measured: 9 months maximum
Secondary outcomes (8)
Threatened Premature Delivery (PAD) rate in each group
The threat of premature delivery is a pathology associating cervical changes and regular and painful uterine contractions occurring between 22 and 36 weeks of amenorrhea + 6 days (HAS).
Cervical changes will be assessed by endovaginal ultrasound of the cervix on at least 1 of the following criteria:
- neck length less than or equal to 25mm
- funnel opening or expansion of the internal orifice of the neck
- protrusion of amniotic membranes in the cervix.
The close and regular frequency of uterine contractions (generalized and intermittent hardening of the uterus lasting 30 to 60 seconds) will be objectified by a tocographic recording: at least 3 contractions in 30 minutes. The pain will be assessed by the patient with the possible help of the visual analogue scale (VAS> = 5).
Measured: 9 months maximum
Fetal hypotrophy rate
Fetal hypotrophy corresponds to a biometry below the 10th percentile according to the growth curve of the French College of Fetal Ultrasound (CFEF).
The diagnosis is based on the measurement during an obstetric ultrasound of the biparietal diameter, head circumference (PC), abdominal diameter, abdominal perimeter (PA) and femoral length (FL).
The fetal weight is estimated according to the Hadlock formula [46] log10 EPF = 1.326 + 0.0107 PC + 0.0438 PA + 0.158 LF - 0.00326 (PA x LF).
Measured: 9 months maximum
Low birth weight
The low birth weight corresponds to a birth weight below the 10th percentile for the term on the CFEF curve.
The weight will be measured within half an hour after giving birth.
Measured: 9 months maximum
Postpartum hemorrhage rate
corresponds to a loss of blood of more than 500 ml within 24 hours between birth and leaving the maternity hospital.
This criterion will be measured by midwives or nurses in the operating room (double collection bag: one for amniotic fluid and the other for blood loss). In postpartum, the loss is estimated daily by the midwives or the physician.
Measured: 9 months maximum
Rate of preeclampsia
Pre-eclampsia is de novo hypertension (SBP> = 140 mmHg or ADP> 90 mmHg) in the second part of pregnancy, with the onset of proteinuria greater than 300 mg / 24h or onset of proteinuria in a woman with chronic hypertension. The hypertension will be objectified on at least two blood pressure measurements in a patient lying down and calm for at least 5 minutes or on a blood pressure holter over 24 hours with a cuff adapted to the body of the patient. Chronic hypertension corresponds to a patient on antihypertensive medication. Proteinuria is defined as the pathological elimination in the urine of a quantity of protein greater than 80 mg / day. The 24-hour urine collection for proteinuria can be done in a hospital setting or on an outpatient basis.
Measured: 9 months maximum
Rate of eclampsia
Eclampsia is defined as the occurrence of seizures, either in the 2nd part of pregnancy, or during childbirth, or in the first 48 hours postpartum, in a woman with preeclampsia.
The occurrence of convulsions in the patient must be validated by a physician or a midwife.
Measured: 9 months maximum
Rate of fetal death in utero
Fetal death from 22 weeks of amenorrhea. Death will be confirmed by the absence of cardiac activity on obstetric Doppler ultrasound.
Measured: 9 months maximum
Spontaneous abortion rate
Early: before 16 SA Late: between 16 and 22 SA. The death of the fetus will be confirmed by examination by the physician or midwife. It should be verified that this is not a voluntary abortion or that he has had medication or a triggering event.
Measured: 9 months maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start11 Jul 2012
- Primary completion12 Feb 2015
- Study completion11 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DengueStudies 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
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Kourou, Centre Hospitalier de l'Ouest Guyanais, Centres de Protection Maternelle Infantile Cayenne, Kourou et Saint-Laurent du Maroni, Private physicians Cayenne, Kourou et Saint-Laurent du Maroni, Private midwife Cayenne, Kourou et Saint-Laurent du Maroni
- Responsible party
- Sponsor
- Investigators
- Gabriel CARLES, Principal investigator, Centre Hospitalier de Saint-Laurent du Maroni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989673
- Sponsor's protocol ID
- CMFdeng
- Acronym
- CMFdeng
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Basurko C, Carles G, Youssef M, Guindi WE. Maternal and fetal consequences of dengue fever during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):29-32. doi: 10.1016/j.ejogrb.2009.06.028. Epub 2009 Jul 24.
PubMed 19632027Carles G, Peiffer H, Talarmin A. Effects of dengue fever during pregnancy in French Guiana. Clin Infect Dis. 1999 Mar;28(3):637-40. doi: 10.1086/515144.
PubMed 10194092Carles G, Talarmin A, Peneau C, Bertsch M. [Dengue fever and pregnancy. A study of 38 cases in french Guiana]. J Gynecol Obstet Biol Reprod (Paris). 2000 Dec;29(8):758-762. French.
PubMed 11139712Basurko C, Everhard S, Matheus S, Restrepo M, Hilderal H, Lambert V, Boukhari R, Duvernois JP, Favre A, Valmy L, Nacher M, Carles G. A prospective matched study on symptomatic dengue in pregnancy. PLoS One. 2018 Oct 3;13(10):e0202005. doi: 10.1371/journal.pone.0202005. eCollection 2018.
PubMed 30281605Basurko C, Matheus S, Hilderal H, Everhard S, Restrepo M, Cuadro-Alvarez E, Lambert V, Boukhari R, Duvernois JP, Favre A, Nacher M, Carles G. Estimating the Risk of Vertical Transmission of Dengue: A Prospective Study. Am J Trop Med Hyg. 2018 Jun;98(6):1826-1832. doi: 10.4269/ajtmh.16-0794. Epub 2018 Apr 19.
PubMed 29692297
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Materno-fetal Consequences of Symptomatic Dengue in Pregnant Wowen in French Guiana
- ClinicalTrials.gov ID
- NCT04989673
- Acronym / sponsor ID
- CMFdeng / CMFdeng
- Conditions
- Dengue, Pregnancy Preterm, Women, Fever, Parturition; Precipitate, Infant, Newborn
- Keywords
- Symptomatic Dengue, Pregnancy Preterm, Vertical transmission, Fetus, French Guiana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Kourou, Centre Hospitalier de l'Ouest Guyanais, Centres de Protection Maternelle Infantile Cayenne, Kourou et Saint-Laurent du Maroni, Private physicians Cayenne, Kourou et Saint-Laurent du Maroni, Private midwife Cayenne, Kourou et Saint-Laurent du Maroni
- Study start
- 11 Jul 2012 (actual)
- Primary completion
- 12 Feb 2015 (actual)
- Study completion
- 11 Jul 2015 (actual)
- First posted
- 4 Aug 2021 (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.
Symptomatic dengue virus infection in pregnant women could affect the mother, fetus and the newborn at birth. The risks of postpartum hemorrhage, prematurity and low birth weight are increased in dengue fever. Cases of vertical transmission have been described. This study therefore proposes to quantify these risks in a pregnant woman presenting a clinical picture of dengue fever through a prospective, longitudinal and comparative study.
Detailed description
The main objective of the study is to compare the occurrence of prematurity between women who presented with symptomatic dengue fever and those who did not. However, febrile syndrome is known to be one of the main major risk factors for prematurity whatever its etiology (National College of French Gynecologists and Obstetricians CNGOF, High Authority of Health HAS). Dividing the unexposed group into 2 groups (group without fever or dengue GNES and group with fever not due to the dengue virus GNEF) is a means of observing on the one hand the effects of symptomatic dengue (the combination of effect of fever and the effect of the dengue virus) on the primary endpoint and on the other hand to observe the effects of fever in the context of another infectious pathology on the primary endpoint. This split also makes it easy to control the number of patient enrollments in each unexposed group.
This study protocol is only interested in investigating the impact of symptomatic dengue fever in pregnant women.
Primary objective: Compare the prematurity rate of the woman with symptomatic dengue fever (exposed group: GE) during her pregnancy compared to the woman who had neither fever nor infection with the dengue virus during her pregnancy (unexposed group without fever: GNES).
Secondary objectives:
- Describe the clinical pictures of symptomatic dengue fever in pregnant women;
- Compare the proportion of rates of prematurity, threat of premature delivery, spontaneous miscarriage, pre-eclampsia, eclampsia and delivery haemorrhage between the GE / GNES group and between the GE / GNEF group ( pregnant women who presented with dengue GE, those who had neither fever nor dengue during their pregnancy GNES and those who presented a fever not due to the dengue virus GNEF);
- Compare the proportion of MFIU and hypotrophy of newborns born to mothers between the GE / GNES group and between the GE / GNEF group;
- Describe the clinical and biological pictures of newborns at birth of mothers who presented with symptomatic dengue fever during their pregnancy (GE)
- Describe the morphological, biometric and velocimetric abnormalities of obstetric doppler ultrasounds of pregnant women who presented with dengue fever during their pregnancy (GE).
- Check for the presence of the dengue virus in the placenta of pregnant women who have had dengue fever during their pregnancy (GE).
- Constitute a direct biological collection (serums, placentas) used for the research of the dengue virus.
Epidemiological, etiological exposed-unexposed, multicentric, dynamic and contemporary with biological collection
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposed group (GE) | – | Other: Biological sampling and collection (serum), Other: Biological sampling and collection (placenta), Other: Questionnaire, Other: Data collectionPregnant women with symptomatic dengue fever, confirmed biologically between the presumed date of conception and the date of delivery. |
| Unexposed group with fever (GNEF) | – | Other: Biological sampling and collection (serum), Other: Questionnaire, Other: Data collectionPregnant women presenting a febrile syndrome not due to the dengue virus between the presumed date of conception and the date of delivery, excluding malaria, rubella, toxoplasmosis, chickenpox, listeriosis, CMV infection and primary HIV infection. |
| Unexposed group without fever or dengue (GNES) | – | Other: Biological sampling and collection (serum), Other: Questionnaire, Other: Data collectionPregnant women exhibiting neither febrile syndrome nor asymptomatic dengue fever between the presumed date of conception and the date of delivery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (11 listed)
- presenting a symptomatic dengue fever, confirmed biologically between the presumed date of conception (date determined after the first trimester dating ultrasound) and the date of delivery.
- not presenting biologically confirmed dengue fever;
- with asymptomatic dengue fever between the presumed date of conception and the date of delivery.
- presenting an infectious syndrome not due to the dengue virus between the presumed date of conception (date determined after the ultrasound dating of the first trimester) and the date of delivery.
- presenting with an infectious syndrome in the context of rubella (before 18 weeks), chickenpox, malaria, listeriosis, toxoplasmosis, primary HIV infection and CMV infection.
Key exclusion criteria (5 listed)
- Person included in the study with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery.
- People included in the study,
- with biologically confirmed dengue fever (symptomatic or not) between the date of inclusion and the date of delivery;
- having presented a febrile syndrome (fever above 38.5 ° C for more than 48 hours) between inclusion and childbirth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sampling and collection (serum)Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups | Other | Exposed group (GE), Unexposed group with fever (GNEF), Unexposed group without fever or dengue (GNES) |
| Biological sampling and collection (placenta)Detection of dengue virus in the placenta of GE patients (additional tube of placenta) | Other | Exposed group (GE) |
| QuestionnaireQuestionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA). | Other | Exposed group (GE), Unexposed group with fever (GNEF), Unexposed group without fever or dengue (GNES) |
| Data collectionCase Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3). | Other | Exposed group (GE), Unexposed group with fever (GNEF), Unexposed group without fever or dengue (GNES) |
Primary outcome
Prematurity rate
Time frame: 9 months maximum
The prematurity rate of each group will be assessed according to the WHO definition: a preterm birth is a birth occurring before the 37th week of amenorrhea and after the 22nd week of amenorrhea of a living fetus of at least equal weight at 500 g. This judgment criterion will be measured by the physician or midwife in charge of the patient, and reported on the RIG and the delivery book of the service. The date of delivery will be determined based on the 1st trimester dating ultrasound. The newborn will be examined by the midwife or pediatrician on the ward and weighed within half an hour after birth. A distinction will be made between medically induced premature delivery (reasons given) and spontaneous.
8 secondary outcomes
Threatened Premature Delivery (PAD) rate in each group
Time frame: 9 months maximum
Fetal hypotrophy rate
Time frame: 9 months maximum
Low birth weight
Time frame: 9 months maximum
Postpartum hemorrhage rate
Time frame: 9 months maximum
Rate of preeclampsia
Time frame: 9 months maximum
Rate of eclampsia
Time frame: 9 months maximum
Rate of fetal death in utero
Time frame: 9 months maximum
Spontaneous abortion rate
Time frame: 9 months maximum
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 4 Aug 2021.
- Background: PubMed 19632027Basurko C, Carles G, Youssef M, Guindi WE. Maternal and fetal consequences of dengue fever during pregnancy. Eur J Obstet Gynecol Reprod Biol. 2009 Nov;147(1):29-32. doi: 10.1016/j.ejogrb.2009.06.028. Epub 2009 Jul 24.
- Background: PubMed 10194092Carles G, Peiffer H, Talarmin A. Effects of dengue fever during pregnancy in French Guiana. Clin Infect Dis. 1999 Mar;28(3):637-40. doi: 10.1086/515144.
- Background: PubMed 11139712Carles G, Talarmin A, Peneau C, Bertsch M. [Dengue fever and pregnancy. A study of 38 cases in french Guiana]. J Gynecol Obstet Biol Reprod (Paris). 2000 Dec;29(8):758-762. French.
- Results publication: PubMed 30281605Basurko C, Everhard S, Matheus S, Restrepo M, Hilderal H, Lambert V, Boukhari R, Duvernois JP, Favre A, Valmy L, Nacher M, Carles G. A prospective matched study on symptomatic dengue in pregnancy. PLoS One. 2018 Oct 3;13(10):e0202005. doi: 10.1371/journal.pone.0202005. eCollection 2018.
- Results publication: PubMed 29692297Basurko C, Matheus S, Hilderal H, Everhard S, Restrepo M, Cuadro-Alvarez E, Lambert V, Boukhari R, Duvernois JP, Favre A, Nacher M, Carles G. Estimating the Risk of Vertical Transmission of Dengue: A Prospective Study. Am J Trop Med Hyg. 2018 Jun;98(6):1826-1832. doi: 10.4269/ajtmh.16-0794. Epub 2018 Apr 19.
- 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.
Gabriel CARLES principal investigator
Centre Hospitalier de Saint-Laurent du Maroni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue and Pregnancy Preterm, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 11 inclusion and 5 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. 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?
Prematurity rate (time frame: 9 months maximum). 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 NCT04989673, which also lists 5 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 4 Aug 2021.