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Zhejiang Da Xue Xue Bao. Yi Xue Ban =... May 2020To evaluate the efficacy of black cohosh extracts (BCE) in improving the low estrogen status induced by postoperative gonadotropin-releasing hormone agonist (GnRHa) in...
OBJECTIVE
To evaluate the efficacy of black cohosh extracts (BCE) in improving the low estrogen status induced by postoperative gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis.
METHODS
Randomized clinical controlled trial about the improvement of low estrogen status caused by GnRHa with the treatment of BCE in patients with endometriosis after laparoscopic surgery were retrieved from Medline (Ovid), PubMed, Cochrane Library, CNKI, CBMdisc, Wanfang and VIP databases before January 2020, and meta-analysis of included studies was performed by Revman 5.3 software.
RESULTS
Seven randomized controlled trials involving 745 patients were included in this study. Meta-analysis results showed that the addition of BCE did not alter hormone levels of patients, including serum estradiol levels [ =1.24, 95% (-4.58, 7.08), >0.05] and luteinizing hormone levels [ =-0.02, 95% (-0.15, 0.11), >0.05]. BCE effectively improved the perimenopausal symptoms induced by low estrogen status:improving hectic fever and sweating [ =0.1, 95% (0.02, 0.47), < 0.01], reducing the occurrence of insomnia symptoms [ =0.23, 95% (0.13, 0.39), < 0.01], improving fatigue [ =0.09, 95% (0.04, 0.20), < 0.01], reducing the occurrence of vaginal dryness [ =0.04, 95% (0.01, 0.30), < 0.01]. BCE affected Kupperman's menopausal index (KMI) score 12 weeks after the surgery [ =-11.50, 95% (-20.09, -2.90), < 0.01] and KMI score 24 weeks after the surgery [ =-23.68, 95% (-39.66, -7.69), < 0.01].
CONCLUSIONS
The limited evidence so far indicates that BCE could efficiently improve perimenopausal symptoms cause by low estrogen status of the patients recieved GnRHa treatment after surgery for endometriosis, but does not alter hormone levels of patients.
Topics: Cimicifuga; Endometriosis; Estrogens; Female; Humans; Plant Extracts
PubMed: 32762163
DOI: 10.3785/j.issn.1008-9292.2020.06.06 -
Sexual and Reproductive Health Matters Dec 2020Contraception is essential to preventing unintended pregnancy. While contraceptive use has increased significantly over the past decade, discontinuation and gaps in use...
Contraception is essential to preventing unintended pregnancy. While contraceptive use has increased significantly over the past decade, discontinuation and gaps in use remain common. Although women cite side effects as the reason for discontinuing or stopping methods, little is known about the specific ways in which contraception affects women's sexual experiences. This systematic scoping review aimed to understand how contraceptive-induced side effects relating to women's sexual experiences have been measured, classified, and explored in the literature, specifically in low- and middle-income countries (LMICs). Studies were eligible for inclusion if they were peer-reviewed, English-language articles published between 2003 and 2018 that examined women's sexual experiences related to their use of modern contraception, including sexual satisfaction, arousal, sexual dysfunction, discomfort, vaginal dryness, sexual frequency, and relationship or partner dynamics. Study populations were restricted to women of reproductive age in LMICs. Twenty-two studies were deemed eligible for inclusion, comprising a range of methods and geographies. Emergent sexual experience themes included: menstrual issues impacting sexual experience; libido; lubrication; sexual pleasure; dyspareunia; and female sexual function. Results highlight the variability in measures used, lack of a women-centred perspective, and void in research outside of high-income countries to study the influence of contraception on women's sexual experiences. Very few studies focused on women's sexual experiences as the primary outcome or predictor. Providers should adopt woman-centred contraceptive counselling that considers women's relationships. Further research is needed to disentangle the nuanced effects of contraception on women's sex lives, contraceptive decision-making, and method continuation.
Topics: Contraception; Contraception Behavior; Developing Countries; Female; Humans; Menstruation; Sexual Behavior
PubMed: 32530748
DOI: 10.1080/26410397.2020.1763652 -
Journal of Menopausal Medicine Dec 2019Menopause is associated with the onset of climacteric symptoms due to low estradiol levels, which may cause insufficient maturation of the vaginal mucosa. Vitamin D may... (Review)
Review
Menopause is associated with the onset of climacteric symptoms due to low estradiol levels, which may cause insufficient maturation of the vaginal mucosa. Vitamin D may regulate the growth and differentiation of cells that are adversely affected due to low estradiol levels, thereby restoring vaginal health. The objective of this systematic review, the first on this subject, was to investigate the effect of vitamin D on the vaginal health of menopausal women. PubMed, Embase, Scopus, Web of Science, and Google Scholar databases and reference lists of hand-searched articles were searched for published studies from February 2000 to November 2018. The selection criteria were as follows: randomized or quasi-randomized trials that compared the effects of vitamin D or related compounds, alone or with calcium, on vaginal health (growth and differentiation of epithelial cells, dryness, acidity [pH]) outcomes in menopausal women. The methodological quality of these studies was examined using the Cochrane tool checklist by two independent investigators, following which the data were extracted. Of six examined studies, two showed that vitamin D administration improved the growth and differentiation of vaginal epithelial cells, improved vaginal pH, and decreased vaginal dryness in menopausal women. Although the level of evidence for the effects of vitamin D on vaginal health is low in our study, we concluded that vitamin D may improve the vaginal health of women, especially during menopause.
PubMed: 32307935
DOI: 10.6118/jmm.19194 -
The Cochrane Database of Systematic... Mar 2020Approximately 80% of breast cancers amongst premenopausal women are hormone receptor-positive. Adjuvant endocrine therapy is an integral component of care for hormone... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Approximately 80% of breast cancers amongst premenopausal women are hormone receptor-positive. Adjuvant endocrine therapy is an integral component of care for hormone receptor-positive breast cancer and in premenopausal women includes oestrogen receptor blockade with tamoxifen, temporary suppression of ovarian oestrogen synthesis by luteinising hormone releasing hormone (LHRH) agonists, and permanent interruption of ovarian oestrogen synthesis with oophorectomy or radiotherapy. Recent international consensus statements recommend single-agent tamoxifen or aromatase inhibitors with ovarian function suppression (OFS) as the current standard adjuvant endocrine therapy for premenopausal women (often preceded by chemotherapy). This review examined the role of adding OFS to another treatment (i.e. chemotherapy, endocrine therapy, or both) or comparing OFS to no further adjuvant treatment.
OBJECTIVES
To assess effects of OFS for treatment of premenopausal women with hormone receptor-positive early breast cancer.
SEARCH METHODS
For this review update, we searched the Specialised Register of the Cochrane Breast Cancer Group, MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 8), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), and ClinicalTrials.gov on 26 September 2019. We screened the reference lists of related articles, contacted trial authors, and applied no language restrictions.
SELECTION CRITERIA
We included all randomised trials assessing any method of OFS, that is, oophorectomy, radiation-induced ovarian ablation, or LHRH agonists, as adjuvant treatment for premenopausal women with early-stage breast cancer. We included studies that compared (1) OFS versus observation, (2) OFS + chemotherapy versus chemotherapy, (3) OFS + tamoxifen versus tamoxifen, and (4) OFS + chemotherapy + tamoxifen versus chemotherapy + tamoxifen.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. Hazard ratios (HRs) were derived for time-to-event outcomes, and meta-analysis was performed using a fixed-effect model. The primary outcome measures were overall survival (OS) and disease-free survival (DFS). Toxicity, contralateral breast cancer, and second malignancy were represented as risk ratios (RRs), and quality of life data were extracted when provided.
MAIN RESULTS
This review update included 15 studies involving 11,538 premenopausal women with hormone receptor-positive early breast cancer; these studies were conducted from 1978 to 2014. Some of these treatments are not current standard of care, and early studies did not assess HER2 receptor status. Studies tested OFS versus observation (one study), OFS plus chemotherapy versus chemotherapy (six studies), OFS plus tamoxifen versus tamoxifen (six studies), and OFS plus chemotherapy and tamoxifen versus chemotherapy and tamoxifen (two studies). Of those studies that reported the chemotherapy regimen, an estimated 72% of women received an anthracycline. The results described below relate to the overall comparison of OFS versus no OFS. High-certainty evidence shows that adding OFS to treatment resulted in a reduction in mortality (hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.78 to 0.94; 11 studies; 10,374 women; 1933 reported events). This treatment effect was seen when OFS was added to observation, to tamoxifen, or to chemotherapy and tamoxifen. The effect on mortality was not observed when OFS was added to chemotherapy without tamoxifen therapy (HR 0.95, 95% CI 0.82 to 1.09; 5 studies; 3087 women; median follow-up: range 7.7 to 12.1 years). The addition of OFS resulted in improved DFS (HR 0.83, 95% CI 0.77 to 0.90; 10 studies; 8899 women; 2757 reported events; high-certainty evidence). The DFS treatment effect persisted when OFS was added to observation, to tamoxifen, and to chemotherapy and tamoxifen. The effect on DFS was reduced when OFS was added to chemotherapy without tamoxifen therapy (HR 0.90, 95% CI 0.79 to 1.01; 5 studies; 2450 women). Heterogeneity was low to moderate across studies for DFS and OS (respectively). Evidence suggests that adding OFS slightly increases the incidence of hot flushes (grade 3/4 or any grade; risk ratio (RR) 1.60, 95% CI 1.41 to 1.82; 6 studies; 5581 women; low-certainty evidence, as this may have been under-reported in these studies). Two other studies that could not be included in the meta-analysis reported a higher number of hot flushes in the OFS group than in the no-OFS group. Seven studies involving 5354 women collected information related to mood; however this information was reported as grade 3 or 4 depression, anxiety, or neuropsychiatric symptoms, or symptoms were reported without the grade. Two studies reported an increase in depression, anxiety, and neuropsychiatric symptoms in the OFS group compared to the no-OFS group, and five studies indicated an increase in anxiety in both treatment groups (but no difference between groups) or no difference overall in symptoms over time or between treatment groups. A single study reported bone health as osteoporosis (defined as T score < -2.5); this limited evidence suggests that OFS increases the risk of osteoporosis compared to no-OFS at median follow-up of 5.6 years (RR 1.16, 95% CI 1.10 to 28.82; 2011 women; low-certainty evidence). Adding OFS to treatment likely reduces the risk of contralateral breast cancer (HR 0.75, 95% CI 0.57 to 0.97; 9 studies; 9138 women; moderate-certainty evidence). Quality of life was assessed in five studies; four studies used validated tools, and the fifth study provided no information on how data were collected. Two studies reported worse quality of life indicators (i.e. vaginal dryness, day and night sweats) for women receiving OFS compared to those in the no-OFS group. The other two studies indicated worsening of symptoms (e.g. vasomotor, gynaecological, vaginal dryness, decline in sexual interest, bone and joint pain, weight gain); however these side effects were reported in both OFS and no-OFS groups. The study that did not use a validated quality of life tool described no considerable differences between groups.
AUTHORS' CONCLUSIONS
This review found evidence that supports adding OFS for premenopausal women with early, hormone receptor-positive breast cancers. The benefit of OFS persisted when compared to observation, and when added to endocrine therapy (tamoxifen) or chemotherapy and endocrine therapy (tamoxifen). The decision to use OFS may depend on the overall risk assessment based on tumour and patient characteristics, and may follow consideration of all side effects that occur with the addition of OFS.
Topics: Antineoplastic Agents, Hormonal; Breast Neoplasms; Chemotherapy, Adjuvant; Female; Gonadotropin-Releasing Hormone; Humans; Premenopause; Randomized Controlled Trials as Topic; Survival Analysis; Tamoxifen; Treatment Outcome
PubMed: 32141074
DOI: 10.1002/14651858.CD013538 -
Maturitas Mar 2020The objective of this systematic review and meta-analysis was to evaluate the efficacy and the effectiveness, as well as the safety and tolerability, of urethral bulking... (Meta-Analysis)
Meta-Analysis
The objective of this systematic review and meta-analysis was to evaluate the efficacy and the effectiveness, as well as the safety and tolerability, of urethral bulking agents (UBAs) in women with mixed or stress urinary incontinence. PubMed, Scopus, and the Cochrane Central Register of Controlled Trials were used to identify relevant articles. In total, 3510 records were found. A total of 42 full texts were evaluated but only 21 (48.8 %) were selected for the qualitative and quantitative analysis. The pooled improvement rate in studies with a follow-up of ≤1 and >1 year was 46.0 % (95 % CI: 37.0 %-57.0 %; I: 88.9 %) and 57.0 % (95 % CI: 39.0 %-74.0 %; I: 89.6 %), respectively. The outcome 'cure/dryness' ranged from 9.1 % to 56.7 %. The pooled cure rate was 26.0 % (95 % CI: 21.0 %-32.0 %; I: 89.9 %) and 21.0 % (95 % CI: 16.0 %-27.0 %; I: 34.2 %) in females with a follow-up of ≤1 and >1 year, respectively. The treatment success rate ranged from 32.7 % to 93.3 % in 12 studies; it was objectively assessed with different tools (e.g., the Stamey scale in 5 studies). The pooled objective treatment success rate was 7.0 % (95 % CI: 59.0.0 %-75.0 %; I: 82.4 %) and 46.0 % (95 % CI: 37.0 %-55.0 %; I: 55.3 %) in women with a follow-up of ≤12 and >12 months, respectively. The percentage of adverse events was 0.4 % (vaginal infection, irritation, lichen sclerosus, worsening urinary incontinence). However, the use of UBAs as the first-line therapy should be demonstrated in more comparative studies (randomized studies MUSs vs. UBAs). UBAs should be considered a first-line surgical therapy only for women with SUI and mixed UI with high anaesthesia risk, elderly patients, or patients reluctant to undergo surgery. Thus, UBAs should not be offered as first-line therapy for those women desiring a "one-time" durable solution for primary or recurrent SUI.
Topics: Humans; Hydrogels; Polymers; Treatment Outcome; Urethra; Urinary Incontinence
PubMed: 32005420
DOI: 10.1016/j.maturitas.2019.12.007 -
Sexual Medicine Reviews Jan 2020The puerperium is a period of adaptation in which various transformations take place in the lives of women and men on their way to becoming mothers and fathers. These...
INTRODUCTION
The puerperium is a period of adaptation in which various transformations take place in the lives of women and men on their way to becoming mothers and fathers. These changes can also have repercussions on their sexual relations. How the couple deals with this transition is crucial to the well-being of the couple and affects how parents relate to the baby.
AIM
This study aimed to explore the factors that influence sexuality in both women and men during postpartum.
METHODS
We conducted a bibliographic review of 236 articles found on the PubMed database and published from 2008 to January 2019.
MAIN OUTCOME MEASURE
The main outcome measure was the impact of various physical, psychological, and sociocultural factors on couples' sexual functioning during postpartum.
RESULTS
The main problems that couples face after childbirth can be classified as (i) psychological changes, such as loss of a sense of self, transitioning to parenthood, taking on the new roles of mother and father, and feelings of abandonment among men; (ii) body changes in women that affect their self-image and perineal trauma; (iii) hormonal changes in women and men that can lead to reduced sexual desire in both and vaginal dryness or dyspareunia in women; (iv) changes in the marital relationship, including changes in each other's roles, taking time for intimacy, and initiating sexual intercourse; (v) sociocultural influences, such as social support, culturally expected roles, and beliefs regarding when to resume sex; and (vi) lifestyle changes, especially with regard to baby care.
CONCLUSION
Sexuality during postpartum is influenced by multiple factors: physical, psychological, and sociocultural. Our findings offer a deeper understanding of how the transition to parenthood affects sexual relationships during the postpartum period. Implications regarding caring for and promoting the sexual health of individuals and couples after childbirth are discussed, and some medical recommendations for parents are offered. Serrano Drozdowskyj E, Gimeno Castro E, Trigo López E, et al. Factors Influencing Couples' Sexuality in the Puerperium: A Systematic Review. Sex Med Rev 2020;8:38-47.
Topics: Dyspareunia; Female; Humans; Libido; Male; Postpartum Period; Sexual Behavior
PubMed: 31447412
DOI: 10.1016/j.sxmr.2019.07.002 -
Lasers in Medical Science Feb 2020A systematic review and meta-analysis was undertaken to assess the efficacy and safety of intravaginal energy-based therapies (laser and radiofrequency) on sexual health... (Meta-Analysis)
Meta-Analysis
A systematic review and meta-analysis was undertaken to assess the efficacy and safety of intravaginal energy-based therapies (laser and radiofrequency) on sexual health of cancer survivors (CS) (breast cancer (BCS) and/or gynecological cancer (GCS)). PubMed, Scopus, Web of Science, and Cochrane Library were searched until 21/02/2019. Quality of reporting, methodology, and body of evidence were assessed using STROBE, MINORS, and GRADE. Primary outcomes were dyspareunia, dryness, and sexual health (FSFI, FSDS-R). Secondary outcomes were burning, itching, dysuria, incontinence, Vaginal Health Index Score (VHIS), microbiome-cytokine evaluation, and adverse events. Main analyses, subgroup analyses, and sensitivity analyses were performed. Eight observational studies (n = 274) were eligible for inclusion. None of the studies evaluated radiofrequency. BCS and BCS-GCS were included in 87% and 13% of studies, respectively. All primary outcomes improved significantly with the exception of FSDS-R (dyspareunia (5 studies (n = 233), standardized mean difference (StdMD) (- 1.17), 95%CI [- 1.59, - 0.75]; p < 0.001; I = 55%), vaginal dryness (4 studies (n = 183), StdMD (- 1.98), 95%CI [- 3.31, - 0.65]; p = 0.003; I = 91%), FSFI (2 studies, n = 28, MD (12.79), 95%CI [7.69, 17.89]; p < 0.001; I = 0%). Itching, dysuria, and VHIS increased significantly, while burning was not improved. Serious adverse events were not observed by any of the studies. Intravaginal laser therapies appear to have a positive effect on dyspareunia, vaginal dryness, and FSFI of CS. However, the quality of evidence is "very low," with no data on intravaginal radiofrequency therapy. Further research with high-quality RCTs and long-term follow-up is needed to evaluate the value of energy-based devices as a therapeutic option for CS with sexual problems.
Topics: Cancer Survivors; Dyspareunia; Female; Humans; Laser Therapy; Sexual Health; Vagina
PubMed: 31396795
DOI: 10.1007/s10103-019-02855-9 -
Climacteric : the Journal of the... Oct 2019Ospemifene is a selective estrogen-receptor modulator approved for treating menopause-related moderate to severe dyspareunia and vaginal dryness, symptoms of...
Ospemifene is a selective estrogen-receptor modulator approved for treating menopause-related moderate to severe dyspareunia and vaginal dryness, symptoms of vulvovaginal atrophy (VVA), in the United States, and for treating menopause-related, symptomatic VVA in women not appropriate for local estrogen therapy in Europe. This review summarizes the effects of ospemifene on bone, including bone biomarker data from a phase 3 vaginal dryness study. Early-phase studies of postmenopausal women showed that ospemifene dose-dependently decreased bone turnover markers versus placebo, similar to raloxifene. A 12-week, phase 3 study of ospemifene 60 mg/day in postmenopausal women showed improvements in all VVA parameters and significantly greater decreases in seven of nine bone biomarkers versus placebo. Lower bone resorption markers with ospemifene were observed regardless of time since menopause (≤5 years or >5 years) or baseline bone mineral density (BMD) (normal [ = 18], osteopenia [ = 164], or osteoporosis [ 21]). Biomarker studies ( 565 who took ospemifene) therefore support a potential role for ospemifene in maintaining bone health (and possibly reducing fracture risk) in postmenopausal women taking it for VVA; however, caution is warranted because data are limited to biochemical markers, rather than fracture and BMD. Although studies show that bone turnover predicts BMD and fractures, any hypothesis about a bone-sparing effect of ospemifene needs testing in rigorous, long-term, phase 3 studies monitoring fractures and BMD.
Topics: Administration, Oral; Atrophy; Bone Density; Female; Humans; Osteoporosis, Postmenopausal; Randomized Controlled Trials as Topic; Selective Estrogen Receptor Modulators; Tamoxifen; Vagina; Vulva
PubMed: 31294631
DOI: 10.1080/13697137.2019.1631789 -
Clinical Breast Cancer Aug 2019Genitourinary syndrome of menopause (GSM) is caused by hypo-estrogenism, resulting in vaginal dryness, pain, dyspareunia, and urinary tract infection. It is more severe... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Genitourinary syndrome of menopause (GSM) is caused by hypo-estrogenism, resulting in vaginal dryness, pain, dyspareunia, and urinary tract infection. It is more severe and common in breast cancer (BC) survivors owing to the severity of induced menopause following treatment (ie, chemotherapy, GnRH agonists/anti-estrogen therapy). It has a detrimental effect on quality of life. The gold standard therapy is topical estrogen, which is highly effective; however, it is contraindicated in patients with BC owing to concerns with recurrence. Recently, vaginal laser therapy has been used to restore vaginal mucosal thickness, lubrication, and elasticity with good effect in menopausal women with GSM. The aim of this study is to assess the impact of vaginal laser therapy on BC-associated GSM.
MATERIALS AND METHODS
This study is a systematic review and meta-analysis.
RESULTS
A total of 48 papers were identified, revealing 10 observational studies of GSM symptoms before and after vaginal laser therapy with no randomized trials. Vaginal laser was effective in treating GSM in BC survivors with improvement in the Vaginal Health Index and the Visual Analogue Scale score for dyspareunia and vaginal dryness, sexual function, and overall satisfaction in the short term with minimal adverse events.
CONCLUSION
Vaginal laser may be effective in treating GSM in BC survivors in the short term, but there are no long-term data on safety and efficacy. More research is needed looking at longer term follow-up, health economic costs, and sub-group analysis as well as the complex interplay between GSM and the other negative impacts of BC therapy on intimate relationships.
Topics: Breast Neoplasms; Cancer Survivors; Female; Female Urogenital Diseases; Humans; Laser Therapy; Menopause; Prognosis; Syndrome
PubMed: 31227415
DOI: 10.1016/j.clbc.2019.04.007 -
Oral progesterone for the prevention of recurrent preterm birth: systematic review and metaanalysis.American Journal of Obstetrics &... Mar 2019The purpose of this study was to perform a systematic review and metaanalysis of randomized controlled trials on oral progesterone compared with placebo or other... (Meta-Analysis)
Meta-Analysis
OBJECTIVE DATA
The purpose of this study was to perform a systematic review and metaanalysis of randomized controlled trials on oral progesterone compared with placebo or other interventions for preterm birth prevention in singleton pregnancies with previous spontaneous preterm birth. The primary outcome was preterm birth at <37 weeks gestation; the secondary outcomes included preterm birth rate at <34 weeks gestation, neonatal morbidity/death, and maternal side-effects.
STUDY
Searches were performed in PubMed, Scopus, ClinicalTrials.gov, PROSPERO, EMBASE, and the Cochrane Register with the use of a combination of words related to "preterm birth," "preterm delivery," "progesterone," "progestogens," and "oral" from inception of each database to April 2018. Additionally, systematic reviews on progesterone for preterm birth prevention that were identified in our search were also reviewed for additional studies. We included all randomized trials of asymptomatic singleton gestations with previous spontaneous singleton preterm birth that had been randomized to prophylactic treatment with oral progesterone vs placebo, no treatment, or other preterm birth intervention. Exclusion criteria included quasirandomized trials, trials that involved women with preterm labor/membrane rupture at the time of randomization or multiple gestations.
STUDY APPRAISAL AND SYNTHESIS METHODS
The risk of bias and quality of evidence were assessed for each study. All analyses were done with an intention-to-treat approach. The primary outcome was incidence of preterm birth at <37 weeks gestation; the secondary outcomes included preterm birth at <34 and <28 weeks gestation, maternal adverse events, maternal serum progesterone level, and neonatal morbidity and death. Summary measures were reported as relative risk or mean difference. I >30% was used to identify heterogeneity.
RESULTS
The search strategy identified 79 distinct studies. Three trials on oral progesterone vs placebo (involved 386 patients: 196 in oral progesterone and 190 in placebo) met the inclusion criteria; there were no studies on oral progesterone vs other intervention that met inclusion criteria. Metaanalysis demonstrated a significantly decreased risk of preterm birth at <37 weeks gestation (42% vs 63%; =.0005; relative risk, 0.68; 95% confidence interval, 0.55-0.84), preterm birth at <34 weeks gestation (29% vs 53%; <.00001; relative risk, 0.55; 95% confidence interval, 0.43-0.71), and increased gestational age of delivery (mean difference, 1.71 weeks; 95% confidence interval, 1.11-2.30) with oral progesterone compared with placebo. There was a significantly lower rate of perinatal death (5% vs 17%; =.001; relative risk 0.32; 95% confidence interval, 0.16-0.63), neonatal intensive care admission (relative risk, 0.39; 95% confidence interval, 0.25-0.61), respiratory distress syndrome (relative risk, 0.21; 95% confidence interval, 0.05-0.93), and higher birthweight (mean difference, 435.06 g; 95% confidence interval, 324.59-545.52) with oral progesterone. There was a higher rate of maternal adverse effects with oral progesterone that included dizziness (relative risk, 2.95; 95% confidence interval, 1.47-5.90), somnolence (relative risk, 2.06; 95% confidence interval, 1.29-3.30), and vaginal dryness (relative risk, 2.37; 95% confidence interval, 1.10-5.11); no serious adverse effects were noted.
CONCLUSION
Oral progesterone appears to be effective for the prevention of recurrent preterm birth and a reduction in perinatal morbidity and mortality rates in asymptomatic singleton gestations with a history of previous spontaneous preterm birth compared with placebo. There were also increased adverse effects with oral progesterone therapy compared with placebo, although none were serious. Further randomized study on oral progesterone compared with other established therapies for the prevention of recurrent preterm birth are warranted.
Topics: Female; Gestational Age; Humans; Infant, Newborn; Pregnancy; Pregnancy, Multiple; Premature Birth; Progesterone; Progestins
PubMed: 31172132
DOI: 10.1016/j.ajogmf.2019.03.001