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Pregnancy clinical trials

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NCT ID: NCT01130324 Withdrawn - Pregnancy Clinical Trials

VIBATIV Pregnancy Registry

Start date: November 2009
Phase:
Study type: Observational [Patient Registry]

The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.

NCT ID: NCT01098214 Withdrawn - Pregnancy Clinical Trials

The Role of Cytokines in Apparently Normal Pregnancies

Start date: April 2010
Phase:
Study type: Observational

To provide rigorous, detailed normative data for diagnostics and comparative studies, to determine relationships between cytokine levels (and other biomarkers) and clinical data, and gain further insight into the pro-/anti-inflammatory cytokine profile of normal midtrimester amniotic fluid.

NCT ID: NCT01082718 Withdrawn - Pregnancy Clinical Trials

Pharmacokinetics of Mefloquine-Artesunate in Pregnant Women With Uncomplicated Plasmodium Falciparum Infection

Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Artemisinin-based combination therapies (ACTs) are now the treatment of choice for malaria in non-pregnant individuals living in areas with established chloroquine resistance; they have been shown to be both safe and highly efficacious. There is rapidly increasing experience with artemisinin derivatives in the 2nd and 3rd trimesters of pregnancy, with over 1,000 well documented cases with no reported serious adverse effects to mother or fetus (WHO Malaria Treatment Guidelines, 2006). Many countries in Latin America have abandoned the previous 1st line regimen of Quinine-Clindamycin for treatment of malaria in pregnancy, a complex and poorly tolerated regimen with low adherence, in favor of ACTs, despite limited safety and pharmacokinetic data on the use of these compounds in pregnant women. Lack of pharmacokinetic data may lead to underdosing of pregnant women, with subsequent reduced efficacy and increased potential for development of resistance. One ACT regimen, Artesunate-Mefloquine, has been developed as a fixed-dose combination (Farmanguinhos Artesunato + Mefloquina), as part of an international collaborative research effort led by Drugs for Neglected Diseases Initiative (DNDi), and manufactured by Farmanguinhos, laboratory of the Brazilian Ministry of Health. Initial clinical trials suggest that it is very well tolerated and efficacious in both pregnant and non-pregnant individuals. The convenient dosing afforded by a fixed drug combination make this a very promising candidate for treatment of pregnant women with malaria. Preliminary pharmacokinetic data from mefloquine monotherapy and prophylaxis suggest that the peak concentration of mefloquine is lowered in pregnant women. Prior to wide-spread adoption of the Artesunate-Mefloquine combination, further studies on safety, efficacy, and dose optimization are imperative. We propose to compare the pharmacokinetics of the fixed combination of mefloquine-artesunate (MA) for treatment of P.falciparum in 28 pregnant women in the second and third trimesters to the pharmacokinetics of this regimen in 28 matched non-pregnant P.falciparum infected women. This will allow us to determine whether the standard adult dose is sufficient for pregnant women.

NCT ID: NCT01005667 Withdrawn - Pregnancy Clinical Trials

Study to Determine if Monitoring of Labor Shortens the Time to Delivery

BirthTrack
Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to test the hypothesis that using the BirthTrack for management of labor shortens the time to delivery and thus improves both maternal and perinatal outcomes.

NCT ID: NCT00936195 Withdrawn - HIV Infections Clinical Trials

Universal Use of EFV-TDF-FTC and AZT-3TC-LPV/r Combinations for HIV-1 PMTCT in Pregnant and Breastfeeding Women : a Phase 3 Trial

UMA
Start date: January 2010
Phase: Phase 3
Study type: Interventional

To assess the maternal and infant safety of a single daily fixed-dose combination of TDF/FTC/EFV (Atripla®), compared to the association of LPV/r (Kaletra® or Aluvia®) and 3TC/ZDV (Combivir®) given to African women to prevent overall MTCT in populations practicing breastfeeding.

NCT ID: NCT00873886 Withdrawn - Pregnancy Clinical Trials

A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women?

NCT ID: NCT00759733 Withdrawn - Pregnancy Clinical Trials

Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease

Start date: July 2008
Phase:
Study type: Observational

Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction is a complex process requiring skilled clinicians and technology such as ECG, long-term monitoring, and echocardiography. A fast, easily obtained blood test for B-type natriuretic peptide (BNP) has been developed that can give evidence for heart muscle stretch and dysfunction among adults with suspected congestive heart failure. Preliminary experience indicates that ventricular dysfunction among OB patients with a history of heart disease can be detected with this serum assay. A prospective cohort design consisting of two groups of pregnant patients; one with a history of cardiac disease and one without, will be followed over the course of the pregnancies and cardiac function will be measured using echocardiography and serum BNP. It is hoped that the blood test for BNP will be a reliable way to help evaluate OB patients with suspected abnormal heart function.

NCT ID: NCT00759278 Withdrawn - Hypertension Clinical Trials

Comparison Fetal Hemodynamic Measurements Antihypertensive Versus Control

Start date: August 2008
Phase:
Study type: Observational

This is a prospective case-control study to evaluate women who are pregnant and take antihypertensive medication for fetal hemodynamics (middle cerebral artery peak systolic flow and umbilical artery Doppler systolic to diastolic ratio) compared to a control group of pregnant women not taking these kinds of medications. The hypothesis is that the investigators expect to observe little to no difference in the comparison between the medication group and the control group.

NCT ID: NCT00503672 Withdrawn - Pregnancy Clinical Trials

Assessment of Activity in Pregnancy Using an Actigraph

Start date: July 2007
Phase: N/A
Study type: Observational

We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain times in their pregnancies.

NCT ID: NCT00329316 Withdrawn - Pregnancy Clinical Trials

Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent

Start date: n/a
Phase: N/A
Study type: Interventional

To examine the preterm delivery rate of a preterm delivery high risk group of pregnant women, using once daily natural progesterone agent.