Low Molecular Weight Heparin and Aspirin in the Treatment of Recurrent Pregnancy Loss: A RCT
Recurrent Pregnancy LossAntiphospholipid Antibody SyndromeTo compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.
Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy...
ObeseOverweight2 moreOverweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population. The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.
A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine...
Labor InductionMisoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements. Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
Mifepristone Induction for Fetal Demise
Intrauterine Fetal DemiseFetal DeathMethods: Double blinded, randomized controlled trial with 1:1 allocation of mifepristone or placebo at initiation of induction of labor for fetal demise 20 weeks estimated gestational age or greater. Hypothesis: Mifepristone will expedite time to delivery of fetus among demise patients, when compared to placebo, and in conjunction with other pharmacologic methods for induction of labor. Expected outcomes: The addition of a progesterone receptor modulator will expedite time to delivery of the fetus and ultimately improve the experience associated with induction of labor for fetal demise.
Medical Management of Late Intrauterine Death.
Cervical PregnancyMaternal Care for Late Fetal DeathThe purpose of this study is to assess the therapeutic efficacy and safety of isosorbide dinitrate-oxytocin in combination in the management of late intrauterine foetal death.
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
Intrauterine Fetal DemiseThe purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.
Thyroxine Therapy for Recurrent Pregnancy Loss in Hypothyroid Women
Recurrent Early Pregnancy LossThyroid DiseasesThe goal of this clinical trial is to investigate the influence of thyroxine supplementation on pregnancy outcomes in women with varying levels of Thyroid-Stimulating Hormone (TSH), who have experienced recurrent pregnancy loss in the first trimester. The main questions it aims to answer are: Does thyroxine treatment improve pregnancy outcomes in women with TSH levels between 2.5 mU/L and 4 mU/L? Is the effect of thyroxine treatment different in women with TSH levels higher than 4 mU/L? Participants will be grouped based on their TSH levels, into two groups - those with TSH levels between 2.5 mU/L and 4 mU/L, and those with TSH levels higher than 4 mU/L. They will then be given thyroxine treatment. Researchers will compare these two groups to see if the pregnancy outcomes differ based on the different TSH levels and thyroxine treatment.
Mothers Working to Prevent Early Stillbirth Study 20-28
Stillbirth and Fetal DeathPerinatal DeathThis project aims to identify factors linked to pregnancy losses occurring between 20 and 28 weeks of pregnancy that can be modified by changing mother's behaviour or healthcare provision. The death of a child before birth (also called stillbirth or miscarriage) has enduring psychological, social and economic effects for women, their families and wider society. In 2015, the stillbirth rate in the UK was higher than comparable countries. The UK government has committed to reduce stillbirths by 50% by 2025. Presently, stillbirths after 28 weeks of pregnancy have reduced by 16% but there has been no change in losses between 20 and 28 weeks of pregnancy with 1,600 losses estimated to occur at this stage of pregnancy each year. Identification of modifiable causes of stillbirth was identified as a research priority by the Stillbirth Priority Setting Partnership which involved over 1,000 participants, one third of whom were bereaved parents. The investigators previously completed a study of 291 women who had a late stillbirth (after 28 weeks of pregnancy) and 733 women who had a live baby in 41 maternity units in the UK. This study identified factors linked to stillbirth which can be changed including the position women go to sleep in, cigarette smoking and caffeine consumption. In addition, the investigators previously found changes in mother's perception of baby's movements, whether women had tests for diabetes or whether women were exposed to domestic violence or stressful situations. These factors can be addressed by different care in pregnancy. Information from this study has been included in national and international guidelines that aim to reduce stillbirth. The investigators will use the same study type to identify factors associated with pregnancy loss between 20 and 28 weeks of pregnancy (early stillbirth). The investigators have asked parents who have experienced the death of a baby at these stages of pregnancy about the design of the study, the questions that would be asked and how best to approach bereaved parents. This led us to include miscarriages from 20-22 weeks of pregnancy that are not usually "counted" in UK stillbirth statistics. The investigators will need 316 women with stillbirth between 20 and 28 weeks of pregnancy and 632 women with an ongoing live pregnancy to participate in the study. All women will complete a questionnaire about themselves, their diet, behaviours and sleep, their baby's movements and pregnancy care. The investigators will compare information between women who have early stillbirth and those who have a live birth to identify factors associated with stillbirth at less than 28 weeks of pregnancy. The study findings will be disseminated in collaboration with patient organisations using effective ways to reach pregnant women. The investigators anticipate the findings from this study will be included in clinical practice guidelines and rapidly translated into antenatal care.
Effect of Sildenafil Citrate on Mid Luteal Phase Uterine Artery Blood Flow in Patients With Recurrent...
Recurrent Pregnancy LossPatients with recurrent pregnancy loss are known to have decreased uterine artery blood flow. Nitric oxide plays a major role in increasing uterine blood flow during the luteal phase. This study is done to evaluate the effects of sildenafil on blood flow indices in the patients with recurrent pregnancy loss due to impaired uterine artery blood flow.
Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss
MicrobiomeRecurrent Pregnancy LossRecurrent pregnancy loss (RPL) is defined as 2 or more consecutive miscarriages1 This condition affects about 1-3% of couples during their reproductive years. The role of vaginal infections in RPL is controversial and microbiological screening is not recommended as per the international guidelines. Current theories suggest that altered vaginal and uterine microbiota may trigger an inflammatory response in the endometrium even without the presence of clinical infection which could affect the success of embryo implantation and future development of pregnancy2 .Changes in the uterine microbiota can lead to chronic endometritis (CE). This condition is caused by continuing inflammation of the endometrium, involving a variety of common bacterial and yeast species and has been associated with RPL3 . Notably, CE can be found in up to 45% of infertile patients4. Current diagnosis of CE is based on histopathological examination, immunohistochemistry assay for CD138 cells and morphological appearance on hysteroscopy. While antibiotic treatment can improve ongoing pregnancy rates in patients with RPL treatment success is still partial and unpredictable. A mechanistic link is yet to be established between vaginal and uterine microbiota and RPL and it is unknown whether restoration of the microbiome in patients with RPL can improve pregnancy outcomes.