Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility...
VaginosisBacterial2 moreBacterial vaginosis (BV) is a common vaginal infection characterized by a pathologic shift in the normal vaginal flora. BV has been associated with a number of poor reproductive outcomes, including infertility, preterm labor and premature rupture of membranes. If BV does disrupt normal embryologic development, then the treatment of BV prior to conception may improve implantation rates and other pregnancy outcomes in the infertile population. This is a prospective, randomized, double-blind, placebo-controlled trial in which infertile women undergoing intrauterine insemination or embryo transfer are screened for BV prior to treatment. Those patients who screen positive for BV will then be randomized into the treatment arm(metronidazole 500mg by mouth twice daily for 7 days) or the control arm (placebo by mouth twice daily for 7 days). The primary outcome, positive pregnancy test rate (i.e. biochemical pregnancy rate), will then be assessed. Secondary outcomes, such as clinical pregnancy rate, miscarriage rate, and live birth rate will also be examined.
The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion
AcupunctureRecurrent Spontaneous Abortion2 moreRecurrent spontaneous abortion (RSA) is a common pregnancy complication in women of reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in clinical practice to treat infertility and abortion. The role of acupuncture in the treatment of infertility is still unclear. The investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were also detected.
Follow-up of Pregnant Women After a Mass Vaccination of Oral Cholera Vaccine (ShancholTM) in Nsanje...
MiscarriageStillbirth1 moreThis study, to be carried out immediately following an emergency, reactive cholera vaccination campaign in Nsanje District, Malawi, will be a cohort study to estimate the safety of killed oral cholera vaccine (OCV), in pregnant women as measured by ShancholTM, on pregnancy outcomes and birth defects. While limited evidence which suggests that the vaccine is safe in pregnant women, this setting will allow investigators to answer this question in a community where more than 100,000 people will receive vaccine with no restrictions on pregnancy status. In past cholera vaccine campaigns including clinical trials, pregnant women were excluded due to lack of safety data. However, in this campaign, the decision by the Ministry of Health is that the benefits of offering vaccine to all individuals regardless of pregnancy status far outweigh any theoretical risk. Here the investigators specifically propose to: Specific Objective 1: To conduct surveillance of pregnant women to detect adverse pregnancy outcomes within communities in Nsanje District, Malawi that received oral cholera vaccine in a reactive vaccination campaign that started on 30 March 2015. Through household surveying and enrollment of pregnant women with monthly follow-up visits, the investigators will determine the cumulative incidence of adverse pregnancy outcomes among vaccinated and unvaccinated women in Nsanje and Chikwawa Districts, Malawi. Specific Objective 2: To compare the cumulative incidence of pregnancy loss (miscarriage and stillbirth) of women who received oral cholera vaccine while they were pregnant to women who were vaccinated and became pregnant after the end of the final round of vaccination in Nsanje and Chikwawa Districts, Malawi. Specific Objective 3: To compare the incidence of newborn malformations in a cohort of infants that had fetal exposure to oral cholera vaccine compared to those without such exposure in Nsanje and Chikwawa Districts, Malawi.
A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients...
Unexplained Recurrent Miscarriage and Recurrent Implantation FailureRecurrent miscarriage(RM) and recurrent implantation failure (RIF) are clinical challenge for clinicians and patients who are desperate for a healthy child.The specific etiology contains chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders, reproductive system infections, autoimmune and environmental factors. However there are still 50% to 60% RM and RIF which don't have a clear cause,mainly associated with alloimmune factors.Among various treatments,lymphocytes active immunotherapy is the most common treatment method, and its clinical efficacy is widely recognized although its action mechanism is not clear so far.
Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage...
Missed MiscarriageMiscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and risks of infection, but also psychological impacts on women and their families. This study will focus on women whose pregnancy sac remains inside the womb (known as a missed miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or oral tablet that makes the womb contract) should be used in the medical treatment of miscarriage. However, there is evidence to suggest that combining this drug with mifepristone (an oral tablet that reduces pregnancy hormones) may be more effective in treating miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo) followed by misoprostol. Neither the participants nor the researchers will know what allocation is decided, which is necessary to test the treatments fairly. The main outcome of interest will be whether miscarriage is complete within 7 days of randomisation. If miscarriage is not complete then further treatment (more tablets or surgery) will be offered. A number of other key outcomes, such as the need for an operation, will also be assessed. We will also study the views and experience of the participants regarding the tablet treatment. We anticipate that 710 women will be required to take part in the study to answer this question with confidence. We estimate that we would be able to recruit this many women in two years.
Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
Complete MiscarriageThe purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Recurrent MiscarriageInfertilityEmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients. Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013). We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.
Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)...
Birth WeightMiscarriage2 moreThe purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy outcomes in rural Bangladesh.
The HYsteroscopic Miscarriage MaNagement Trial: A Pilot RCT Investigating a Novel Management Pathway...
Retained Products After MiscarriagePregnancy tissue can be found remaining in the womb in up to 20% of women following a miscarriage. These "retained products of conception" (RPOC), which are diagnosed by transvaginal ultrasound, can cause prolonged bleeding, pain, infection, impaired fertility and therefore further psychological distress. Ineffective medical and surgical interventions place considerable burden on affected women and utilise scarce health care resources. Additionally, surgery is performed 'blindly' using a suction tube or metal curette where risks include perforation of the womb and scarring of the womb lining, both of which lead to delayed fertility and in the worst circumstances, infertility. There is no current guidance on how to best investigate and manage RPOC. New surgical equipment allows RPOC removal under vision, using a specially designed telescope placed inside the womb (hysteroscopy). This precise technique may more successfully and less traumatically remove RPOC, minimising ongoing bleeding, the risk of womb perforation and scar tissue formation, thereby reducing the risk of infertility. The investigators propose a pilot randomised controlled trial using routine transvaginal ultrasound to diagnose RPOC in women who choose non-surgical management of a first-trimester (≤14 weeks) miscarriage. This scan will be done 8 weeks post-miscarriage diagnosis. Women who have RPOC on this scan will be randomised (in a 1:1 ratio) to receive outpatient hysteroscopy ('OPH') or 'standard treatment' (expectant, medical, surgical and/or antibiotic treatment). Women who had RPOC will be followed-up at 14 weeks after randomisation to explore clinical outcomes (symptoms, quality of life) and use of additional healthcare resources (e.g. additional investigations / treatments / hospitalisations). All patients, no matter whether they were diagnosed with RPOC or not, will be followed up at 26 weeks and 52 weeks after randomisation/ultrasound scan to determine clinical pregnancy rates and pregnancy outcomes. All patients who have had a miscarriage or have not fallen pregnant since entering the trial will be offered a hysteroscopy to see if there are any conditions affecting the womb lining which may be contributing to pregnancy failure.
Insertion of an Intrauterine Device (IUD) After Medical Abortion
Intrauterine Device ExpulsionMedical Abortion1 moreThe purpose of this study is to determine the expulsion and continuation rate of an intruterine device (IUD) placed immediately after medical abortion. Our hypothesis is that immediate-placement of an IUD after completed medical abortion will have a similar expulsion and continuation rate to traditional placement (4-6 weeks after pregnancy).