Evaluating the clinical efficacy and safety of progestogens in the management of threatened and recurrent miscarriage in early pregnancy-A review of the literature (original) (raw)
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Zenodo (CERN European Organization for Nuclear Research), 2019
Most recent publications offer the opportunity not only to look at large studies, but also to be able to compare the effect of the use of micronized progesterone or dydrogesterone for prevention of recurrent (habitual) miscarriage. Micronized progesterone and dydrogesterone have a similar partial effect pattern, which does not induce unwanted effects, when used in pregnancy. Also their major actions regarding implantation, preparation of the endometrium, blood flow increase, spiral artery development, uterine quiescence, cervical rigidity and protection of the semi-allogenic fetus not to be attacked by the maternal immune system, for instance regulating the Th1-and Th2-cytokines to establish and continue to have a dominance of Th2-cytokine action and protection against these effects which are associated with lower circulating progesterone. Both studies under consideration have included women with a history of three or more previous miscarriages and other non-endocrine or endocrine abnormalities have been ruled out. Under these provisions prevention of recurrent (habitual) miscarriage compared with a placebo group and a control group without a history of recurrent (habitual) miscarriage in a prospective, randomized fashion resulted in the dydrogesterone group in a recurrent (habitual) miscarriage rate of 6.9%, placebo group 16.8% and the control group 3.5%. The dose was 2 x 10 mg daily starting between 4-8 weeks of gestation until the 20st weeks of gestation. In 2015 an even larger study was done with micronized progesterone with a dose of micronized progesterone 2 x 400 mg a day vaginally. This application was started not later than 6 weeks of gestation and ended at 12 weeks of gestation. The live birth rate was not significant between the groups (65,8 % for micronized progesterone versus 63,3% placebo(RR1.04; 95%CI, 0,99-1,15). Together with other studies this indicates that dydrogesterone significantly improves pregnancy outcome in contrast to vaginal progesterone in women with recurrent pregnancy loss.
Comparison of Various Progesterone Drugs in Reducing Miscarriages
Pakistan Journal of Medical and Health Sciences, 2021
Background: Threatened abortion is a common complication of pregnancy. In order to prevent miscarriage progesterone in various forms is administered in patients. This is done to allow pregnancy to proceed further beyond twenty week of gestation. Aim: To compare gravibinan (injected) with utrogestan/cyclogest (intra vaginal administration) in reduction of miscarriages. Study design: Case control study Place and duration of study: Department of Obstetrics & Gynecologiy, Mohtrama Benzair Bhutto Shaheed Medical College Mirpur and Department of Pediatric, Shaikh Zayed Hospital Lahore from 1st April 2020 to 30th September 2020. Methodology: Pregnant women, who had vaginal bleeding until 20 weeks of their pregnancy, were assessed for inclusion. Participants were divided into three groups. Group A was given gravibinan, Group B was given utrogestan and Group C was given cyclogest. Results: Women infested with gravibinan had 20% those who still had miscarriage while the number of miscarriages...
Oral versus Vaginal Micronized Progesterone for the treatment of threatened miscarriage
Pakistan Journal of Medical Sciences, 2021
Objectives: This study was planned with an aim to find out the effectiveness of oral versus vaginal micronized progesterone for the treatment of threatened miscarriage. Methods: This randomized controlled trial was conducted at The Department of Obstetrics and Gynaecology, Nishtar Hospital Multan, from August 2019 to January 2020. A total of 136 pregnant women, aged 18 to 45 years having vaginal bleeding were included and divided into two groups (68 women in each group). Participants in the Group-A were given oral micronized progesterone as 200mg twice a day while Group-B participants were given vaginal progesterone suppository 400mg once a day. All women were followed up until 20th week of their pregnancy. Outcome was labeled as prevention of miscarriage if woman had no bleeding per vagina and pregnancy went beyond 20th weeks of gestation. Results: In a total of 136 women enrolled, mean age was noted to be 30.85+3.34 years. Overall, mean gestational age was noted to be 9.3+2.7 week...
Efficacy of Progesterone in the Management of Threatened Miscarriage
Journal of Evidence Based Medicine and Healthcare, 2020
BACKGROUND There is a great probability of foetal demise and abnormal outcomes in the first trimester of a recognized pregnancy. 20% pregnancies have first trimester complications out of which the most common is miscarriage. Threatened miscarriage is a risk factor occurring in about 20-25% of confirmed pregnancies which may progress or resolve. Inadequate progesterone secretion has been implicated in the aetiology of miscarriage. The current study was undertaken to study the efficacy of progesterone in the management of first trimester threatened miscarriage. METHODS A prospective randomized clinical trial was conducted in a rural tertiary health care center from Jan 2018 to March 2019. A total of 100 pregnant women who had a viable pregnancy who were admitted for threatened abortion in the first trimester, fulfilling the inclusion and exclusion criteria, were selected after taking an informed consent. Patients were further divided into 2 groups of 50 patients each. Group A was treated with progesterone and Group B was given supportive treatment without progesterone. They were observed for relief of symptoms, and progression to second trimester or spontaneous miscarriage. RESULTS Parameters like age, gravidity, period of gestation and body mass index at the time of admission did not have a significant difference between the two groups. Symptoms like vaginal bleed and abdominal pain reduced in 54% and 52% of patients who received progesterone respectively; while, vaginal bleed and abdominal pain reduced only in 40% and 38% of patients who received only symptomatic treatment respectively. 54% of patients who received progesterone and 38% of patients who received only symptomatic treatment could continue the pregnancy further. CONCLUSIONS Pregnant women with first trimester threatened miscarriage have a great risk for spontaneous loss of pregnancy. Progesterone may help clinically, but has no statistically significant improvement in the outcome of pregnancy. Further trials are required utilizing other forms and dosages of progesterone and other routes of administration.
The Role Of Progestogens In Threatened And Idiopathic Recurrent Miscarriage
International Journal of Women's Health
It is well known that progesterone plays a major role in the maintenance of pregnancy, particularly during the early stages, as it is responsible for preparing the endometrium for implantation and maintenance of the gestational sac. The management of pregnant women at risk of a threatened or idiopathic recurrent miscarriage is complex and critical. Therefore, a group of obstetricians and gynecologists practicing in Saudi Arabia gathered to update the 2014 Saudi guidelines for threatened and recurrent miscarriage management. In preparation, a literature review was conducted to explore the role of oral, vaginal, and injectable progestogens: this was used as a basis to develop position statements to guide and standardize practice across Saudi Arabia.
The role of dydrogesterone in recurrent (habitual) abortion
The Journal of Steroid Biochemistry and Molecular Biology, 2005
The published evidence regarding the administration of dydrogesterone in the treatment of habitual abortion is summarised in this review. Habitual abortion is defined as the loss of three or more consecutive pregnancies without known maternal or foetal pathology. The immunology of early pregnancy seems to determine the rejection or non-rejection of the allogenic embryo. When peripheral mononuclear cells from recurrent aborters are incubated with progesterone or dydrogesterone in vitro, T-helper (Th)2 cytokines such as interleukin (IL)-4 and IL-6 markedly increase whereas the Th1 cytokine interferon-␥ decreases. Additionally, both progesterone and dydrogesterone are thought to inhibit the activity of natural killer cells at the foeto-maternal interface in humans. Progesterone-induced blocking factor (PIBF) mediates the immunological effects of progesterone and dydrogesterone in pregnancy. It affects various phases of the maternal immune response involving both the cellular and humoral immune system, exerts anti-abortive effects and inhibits the release of arachidonic acid. It also favours the production of socalled asymmetric, pregnancy-protecting antibodies. In rodents, blockade of this factor results in the termination of pregnancy and in women considerably lower levels are found in those with threatened abortion or pre-term labour. In order to draw final conclusions as to the usefulness of dydrogesterone in women with a history of recurrent miscarriage, further controlled, blinded, randomised clinical trials are needed.
2021
<strong>Background& Objectives:</strong> To compare the efficacy of progesterone alone versus progesterone plus human chorionic gonadotropin for management of threatened miscarriage. <strong>Study design:</strong> Randomized controlled trial <strong>Place & duration of study:</strong> The study was carried out in department of Obstetrics & Gynecology, CMH Lahore for six months from 12" July 2018 to 12th Jan 2019. <strong>Methods:</strong> One hundred females with threatened miscarriage fulfilling inclusion criteria were divided in two groups. In group A, 50 females were given progesterone in oral tablet form plus human chorionic gonadotropin (hCG) as intra-muscular injection, while in group B, 50 females were given (oral only) progesterone till 14 weeks. Females were followed up in OPD on weekly basis till 14 weeks of gestation and efficacy of treatment was compared. Efficacy was defined as successful treatment leading to continui...
A Randomized Trial of Progesterone in Women with Recurrent Miscarriages
The New England journal of medicine, 2015
Background Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain. Methods We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation. Results A total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally wit...
The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians, 2017
The current study aims to evaluate the effect of peri-conceptional progesterone started early in the luteal phase before confirmation of pregnancy in preventing miscarriage in women with history of unexplained recurrent miscarriage (RM). The current study was a randomized double blind controlled trial (NCT01608347) conducted at Assiut Women's Health Hospital from 2012 through 2015 included patients of unexplained RM. Participants were randomly assigned to receive either 400 mg progesterone pessaries or placebo twice daily, started in the luteal phase and continued after a positive pregnancy test till 28 weeks of gestation. The main study outcome was the miscarriage rate. Seven hundred women were enrolled (n = 350 in each group). The miscarriage rate was significantly lower in progesterone group (12.4% vs. 23.3% in the placebo group, P = 0.001). There was significant improvement in rate of pregnancy continuation beyond 20 weeks as well as the live birth rate in the progesterone g...