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Pregnant Women clinical trials

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NCT ID: NCT03036384 Completed - Pregnant Women Clinical Trials

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

Start date: March 2016
Phase: Phase 2
Study type: Interventional

Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)

NCT ID: NCT02973048 Completed - Pain Clinical Trials

Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

Start date: March 12, 2018
Phase: Phase 3
Study type: Interventional

Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.

NCT ID: NCT02923882 Completed - Pregnant Women Clinical Trials

$100Kitchen and Low-birth-weight Study in Rural Bangladesh

Start date: April 2013
Phase: Phase 2
Study type: Interventional

Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries. About 28% of all neonatal deaths worldwide are directly attributed to LBW. Exposure to biomass fuel during cooking is associated with LBW. There is unlikely to be any significant change in the use of biomass fuels in the near future, therefore, interventions targeted to reduce the harmful effects on poor pregnancy outcomes is warranted. To address this need, the investigators proposed a locally-made inexpensive prefabricated model of the "100-dollar-kitchen"($100Kitchen) with an improved cookstove for resource-poor settings. The improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and thus, provided safeguard to the pregnant women using these fuels. This study has been measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less likely to give birth to a LBW newborn. A cluster-randomized controlled trial has been adopted in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12 weeks gestational age enrolled for each intervention and control area respectively and followed-up through 42-days post-delivery. Birth outcomes have been noted and the newborns have been weighted within 72-hrs of the delivery. Non-invasive maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between the intervention and control groups have also been measured.

NCT ID: NCT02904473 Completed - Pregnant Women Clinical Trials

Goals for Reaching Optimum Wellness (GROWell)

Start date: November 2016
Phase: N/A
Study type: Interventional

This is a pilot study to assess the feasibility, acceptability and preliminary efficacy of the GROWell diet intervention. The objective of this study is to determine whether the GROWell intervention can help transition women from consuming a Western diet to consuming a prudent diet (characterized by consumption of primarily fruits, vegetables, healthy fats, lean proteins, and whole grains) during pregnancy. Efficacy will be measured as change in dietary components, using a Food Frequency Questionnaire (FFQ) at baseline and at a follow up visit at 37 weeks gestation. The GROWell intervention is a mobile health technology that uses interactive text messaging and dietician coaching calls, and may be effective in transitioning pregnant women from a Western to a prudent diet during an approximately 6 month intervention period. GROWell results will be measured against an Attention Support Control (ASC) arm, where participants will receive messaging that is pregnancy rather than diet focused, and a Usual Care (USC) arm, where participants will not receive text messages or study coaching. Results from this study will be used to support a grant submission for a larger study, aiming to investigate the GROWell intervention and prudent diet consumption as preventatives against postpartum depression.

NCT ID: NCT02868944 Completed - Pregnant Women Clinical Trials

Interest of the Injection of Morphine, in Addition to a Local Anesthetic When Performing a Combined Spinal-epidural for Labor Analgesia

MASEA
Start date: August 2014
Phase: Phase 3
Study type: Interventional

The addition of morphine to a local anesthetic when performing an epidural analgesia during labor analgesia has improved the efficiency and the action duration of analgesia. One limitation of this technique is the time of installation of the analgesic effect (about 30 minutes) when using the only epidural. Therefore, the technique of sequential combined spinal epidural was introduced. This is to shorten the installation time by direct injection into the cerebrospinal fluid. This allows a good efficiency in less than 10 minutes. It has been shown that low doses of sufentanil (strong opioid) in spinal anesthesia could potentiate the effect of the local anesthetic.

NCT ID: NCT02788383 Recruiting - Pregnant Women Clinical Trials

Fetal RhD Genotye Non Invasive Prenatal Determination

Start date: June 2016
Phase: N/A
Study type: Observational

Actually, our center is doing the prenatal determination of RhD fetal genotype in all RhD negative pregnant women. The investigator want to demonstrate that this is an useful and efficient method.

NCT ID: NCT02523157 Completed - Mental Health Clinical Trials

Wellbeing in Pregnancy: Evaluating an Intervention to Improve Women's Emotional Wellbeing in Pregnancy

WiP
Start date: August 2015
Phase: N/A
Study type: Interventional

The Wellbeing in Pregnancy (WiP) project is an online pilot randomized controlled trial which aims to evaluate an intervention to improve women's emotional wellbeing in pregnancy.

NCT ID: NCT02323711 Withdrawn - Cesarean Section Clinical Trials

Dressing Versus Glue (2-Octyl Cyanoacrylate) for Coverage of the Skin Incision After Closure During Cesarean Delivery

Start date: January 2015
Phase: N/A
Study type: Interventional

This study is investigating the relative risks and benefits of using two common materials for coverage of the skin incision at cesarean delivery. We will perform the first prospective and the first randomized controlled trial examining the use of a standard postoperative dressing versus skin glue for coverage of the closed skin incision after cesarean delivery. The hypothesis is that using skin glue for coverage of the incision will be associated with decreased wound complications and increased patient satisfaction.

NCT ID: NCT02020083 Completed - Pregnant Women Clinical Trials

Placental Transfer of Tenofovir

TDF-PTP
Start date: February 2013
Phase:
Study type: Observational

The purposes of this study are to determine whether transporters expression levels and drug interaction between TDF and FTC could contribute to modulate the placental transfer of this drug or. To test this hypothesis, an ex vivo model known as "the perfused ex vivo cotyledon model" allows to reproduce the conditions of the third trimester of pregnancy

NCT ID: NCT01687634 Completed - Breast Feeding Clinical Trials

Home Visiting for Low Income, Pregnant Women

Start date: October 2012
Phase: N/A
Study type: Interventional

In the Pico-Union/Koreatown community of Los Angeles investigators are designing a preventive health care model that increases the opportunities for families to make healthy choices -- in their homes, schools & communities. The project's key element is: Lay community health workers (paraprofessionals) - Mentor Mothers (MM) (promotoras) - who make home visits to pregnant mothers & newly-delivered mothers who have agreed to participate in the research study. Investigators hope to achieve the following outcomes: 1) lower maternal BMI at 6 months post-birth; 2) longer duration of breastfeeding; 3) less alcohol, smoking, and drug use during pregnancy; and 4) increased and consistent prenatal and postnatal healthcare adherence. Investigators will implement the study with 6 MMs, who will maintain an average caseload of 16 women each across an 18-month period. Each participant will be visited (or receive the intervention by telephone) twice per month. Separate Assessment Team members will conduct assessments at: Baseline, within a week of birth of the target child, and 6 months from birth.