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Pregnancy Complications clinical trials

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NCT ID: NCT01273584 Completed - Obesity Clinical Trials

Metformin in Obese Non-diabetic Pregnant Women

MOP
Start date: October 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Obesity is on the rise in all developed countries. Of particular concern is that more young people including children are being recognised as being overweight or obese. We know from a recent large national enquiry into all maternal and child deaths in the UK, known as CEMACH, that obesity is a major risk both for the mother and her child. When all deaths in women during pregnancy are analysed, obesity comes out as the most common risk factor. Babies of obese mothers are more than 3 times as likely to need admission to the Neonatal Intensive Care Unit. Traditionally, obesity is treated by lifestyle measures encouraging healthy eating and increasing physical activity. Unfortunately these measures are often insufficient to produce significant improvements in weight. If obese women gain little or even no weight during pregnancy, the outcome of the pregnancy is known to be improved. This was shown in a very large study of more than 120, 000 obese women. The drug metformin has been used for years in the treatment of diabetes and more recently for polycystic ovary syndrome (PCOS). Studies in pregnant PCOS women and women with diabetes in pregnancy have shown it to be safe and effective. Fortunately it is relatively cheap and taken as a tablet with meals. Metformin has the great advantage of not causing weight gain and often leads to a small amount of weight loss. It works by improving the body's sensitivity to insulin which is important as resistance to insulin is common in obesity. We have a lot of experience using metformin to treat women with diabetes in pregnancy where it is greatly beneficial. We now wish to examine its potential for obese women who do not have diabetes. We are hoping to show that it will benefit these women by causing less weight gain, less high blood pressure, and less diabetes. We anticipate babies will also have better birth weights, will be easier to deliver naturally, will not need to go to special care baby units and will be healthier.

NCT ID: NCT01165775 Completed - Clinical trials for Pregnancy Complications

Continuous Glucose Monitoring in Pregnant Women Undergoing Betamethasone Therapy

Start date: July 2010
Phase: N/A
Study type: Observational

We hope to clarify how betamethasone affects glucose levels in the mother in the days after receiving the drug. This understanding will hopefully allow us to better anticipate the risk of maternal hyperglycemia and therefore establish more appropriate monitoring of maternal glucose to prevent maternal and neonatal complications of hyperglycemia.

NCT ID: NCT01050647 Completed - Clinical trials for Pregnancy Complications

Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

Start date: February 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

NCT ID: NCT00967382 Completed - Pregnancy Clinical Trials

TIPPS: Thrombophilia in Pregnancy Prophylaxis Study

TIPPS
Start date: July 2000
Phase: Phase 3
Study type: Interventional

The TIPPS trial seeks to determine the safety and effectiveness of low-molecular-weight heparin (LMWH), an anticoagulant, in preventing placenta mediated pregnancy complications and venous thromboembolism (VTE) in women with thrombophilia. Thus, the principal research question is: can LMWH prevent thrombosis in the leg veins, pulmonary arteries and placental vessels, thereby reducing the risk of deep vein thrombosis, pulmonary embolism (PE), intrauterine growth restriction (IUGR), preeclampsia, miscarriage and stillbirth?

NCT ID: NCT00901758 Completed - Breech Presentation Clinical Trials

Intravenous (IV) Nitroglycerin for Versions in Multiparous Women

INVERT (02)
Start date: March 2003
Phase: N/A
Study type: Interventional

Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV). Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials. This study is designed to answer the following questions for multiparous women: Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?

NCT ID: NCT00896311 Completed - Breech Presentation Clinical Trials

Intravenous (IV) Nitroglycerin for Versions in Nulliparous Women

INVERT (01)
Start date: March 2003
Phase: N/A
Study type: Interventional

Breech presentations (where a baby presents with feet or bottom down) have an increased risk of perinatal and neonatal complications, and are usually delivered by cesarean section. As an alternative, so that the baby can be delivered vaginally, an attempt can be made to turn the baby so that it is head down: this manoeuvre is called an external cephalic version (ECV). Drugs that relax the uterus (tocolytic agents) are sometimes used to help improve ECV success rates. Nitroglycerin is a tocolytic agent, but intravenous nitroglycerin has not been tested as an agent to help ECV. There is some suggestion that nitroglycerin may be more helpful in women who have not previously been pregnant (nulliparous women) than in women who have been pregnant more than once (multiparous women), and so we have planned two trials. This study is designed to answer the following questions for nulliparous women: Will administration of IV nitroglycerin for uterine relaxation improve ECV success rates? Will an increase in ECV success result in a decreased cesarean section rate?

NCT ID: NCT00821379 Completed - Clinical trials for Pregnancy Complications

CoPPer Study - Complications of Polycystic Ovary Syndrome (PCOS) Pregnancy: Evaluating Risk

CoPPer
Start date: April 2008
Phase: N/A
Study type: Observational

The CoPPer study is a follow-up study of women diagnosed with Polycystic Ovary Syndrome (PCOS). Women will be included pre-conceptional and followed-up until after delivery. The investigators will design a multivariate prediction model of pregnancy outcome in women with PCOS with the intention to define intervention strategies for the future.

NCT ID: NCT00795561 Completed - Pregnancy Clinical Trials

Management of Nausea and Vomiting of Pregnancy

DIM
Start date: April 2009
Phase: N/A
Study type: Interventional

Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalization overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United States of America. The investigators aim to conduct a randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day and results in significantly greater patient satisfaction compared with standard inpatient management.

NCT ID: NCT00746551 Completed - Anemia Clinical Trials

Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment

EIVF
Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.

NCT ID: NCT00700232 Completed - Clinical trials for Intrahepatic Cholestasis of Pregnancy

ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls

Start date: July 2006
Phase: N/A
Study type: Observational

Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established. The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.