Progesterone therapy for prevention of recurrent spontaneous preterm birth in a minority patient population: a retrospective study (original) (raw)
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OBJECTIVE: Randomized controlled trials (RCTs) have recently compared intramuscular 17-alpha-hydroxy-progesterone caproate (17-OHPC) to vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singletons with prior SPTB. The aim of this systematic review with meta-analysis was to evaluate the efficacy of vaginal progesterone compared with 17-OHPC in prevention of SPTB in singleton gestations with prior SPTB. METHODS: Searches were performed in electronic databases. No restrictions for language or geographic location were applied. We included all RCTs of asymptomatic singleton gestations with prior SPTB who were randomized to prophylactic treatment with either vaginal progesterone (i.e. intervention group) or intramuscular 17-OHPC (i.e. comparison group). The primary outcome was SPTB<34 weeks. Secondary outcomes were SPTB<37 weeks, <32 weeks, <28 weeks and <24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Three RCTs (680 women) were included. The mean gestational age at randomization was about 16 weeks. Women were given progesterone until 36 weeks or delivery. Regarding vaginal progesterone, one study used 90 mg gel daily; one 100 mg suppository daily; and the other one 200 mg suppository daily. All the included trials used 250 mg 17-OHPC weekly as comparison group. Women who received vaginal progesterone had a significantly lower rate of SPTB<34 weeks (17.5% vs 25.0%; RR 0.71, 95% CI 0.53 to 0.95; low quality of evidence) and SPTB<32 weeks (8.9% vs 14.5%; RR 0.62, 95% CI 0.40 to 0.94; low quality of evidence) compared to women who received 17-OHPC. There were no significant differences in the rate of SPTB<37 weeks, SPTB<28 weeks and SPTB<24 weeks. The rate of women who reported adverse drug reactions was significantly lower in the vaginal compared to 17-OHPC group (7.1% vs 13.2%; RR 0.53, 95% CI 0.31 to 0.91; very low quality of evidence). Regarding neonatal outcomes, vaginal progesterone was associated with a lower rate of neonatal intensive care unit admission compared to 17-OHPC (18.7% vs 23.5%; RR 0.63, 95% CI 0.47 to 0.83; low quality of evidence). QUALITY OF EVIDENCE: For comparison of 17-OHPC vs vaginal progesterone, the quality of evidence was downgraded for all outcomes by at least one degree due to imprecision (the optimal information size was reached) and by at least one degree due to indirectness (different interventions). CONCLUSIONS: Daily vaginal progesterone started at about 16 weeks (either suppository or gel) is a reasonable, if not better, alternative to weekly 17-OHPC for prevention of SPTB in women with singleton gestations and prior SPTB. However, the quality level of the summary estimates was low/very low as assed by GRADE, indicating that the true effect may, or is even likely to, be substantially different from the estimate of the effect.
American journal of obstetrics and gynecology, 2015
Prematurity is the leading cause of neonatal morbidity and mortality amongst non-anomalous neonates in the United States. Intramuscular 17-alpha hydroxyprogesterone caproate (17OHP-C) injections reduce the risk of recurrent prematurity by approximately one third. Unfortunately, prophylactic 17OHP-C is not always effective, and one-third of high-risk women will have a recurrent PTB despite 17OHP-C therapy. The reasons for this variability in response are unknown. Previous investigators have examined the influence of a variety of factors on 17OHP-C response, but have analyzed data used a fixed outcome of 'term' delivery to define progesterone response. We hypothesized that the demographics, history, and pregnancy course among women who deliver at a similar gestational age with 17-alpha hydroxyprogesterone caproate (17OHP-C) for recurrent spontaneous preterm birth (SPTB) prevention differs when compared to those women who deliver later with 17OHP-C, and that these associations ...
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2016
To compare the efficacy of intramuscular hydroxyprogesterone caproate with that of vaginal progesterone for prevention of recurrent preterm birth. A prospective randomized controlled trial was conducted at a US tertiary care center between June 1, 2007, and April 30, 2010. Women with singleton pregnancies (16-20 weeks) and a history of spontaneous preterm birth were randomly allocated using a computer-generated randomization sequence to receive either a weekly intramuscular injection of hydroxyprogesterone caproate (250 mg) or a daily vaginal progesterone suppository (100 mg). Participants, investigators, and assessors were not masked to group assignment. The primary outcome was birth before 37 weeks of pregnancy. Per-protocol analyses were performed: participants who completed follow-up were included. Analyses included 66 women given intramuscular progesterone and 79 given vaginal progesterone. Delivery before 37 weeks was recorded among 29 (43.9%) women in the intramuscular proges...
Journal of Maternal-Fetal and Neonatal Medicine, 2010
Evaluation of an outpatient 17 α-hydroxyprogesterone caproate (17P) administration programme. A retrospective analysis of data collected from patients with a history of preterm birth (PTB) and current singleton gestation enrolled between 16.0 and 20.9 weeks&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39; gestational age (GA) for weekly outpatient 17P administration and nursing assessment between 7/2004 and 12/2007 was conducted (n=3139). The population was mostly white (50.3%), 18-35 years old (77.7%), and married (67.0%). Median GA at 17P initiation and stop was 17.4 (16.0, 20.9) weeks and 35.1 (18.6, 37.4) weeks. Mean injections per patient were 16.5±4.9, at an interval of 7.2 days. Median GA at delivery was 37.3 (18.6, 44.0) weeks. Rate of recurrent spontaneous PTB was 29.8%, with 15.5% and 7.0% with PTB at &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;35 and &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;32 weeks. This represents the largest cohort reported to date of patients prescribed 17P therapy in clinical practice to prevent recurrent spontaneous PTB.
Progesterone for prevention of recurrent preterm birth: Impact of gestational age at prior delivery
American Journal of Obstetrics and Gynecology, 2004
Objective: Preterm birth occurs in 1 of 8 pregnancies and may result in significant morbidity and mortality. 17-alpha hydroxyprogesterone caproate (17-OHP caproate) has been found to be efficacious in reducing the risk of subsequent preterm delivery in women who have had a previous spontaneous preterm birth (sPTB). This analysis was undertaken to evaluate if 17-OHP caproate therapy works preferentially depending on the gestational age at previous spontaneous delivery. We hypothesized that treatment with 17-OHP caproate is more effective in prolonging pregnancy depending on the gestational age of the earliest previous preterm birth (20-27.9, 28-33.9 vs 34-36.9 weeks).
Ultrasound in Obstetrics & Gynecology, 2017
Objective Randomized controlled trials (RCTs) have recently compared intramuscular 17α-hydroxyprogesterone caproate (17-OHPC) with vaginal progesterone for reducing the risk of spontaneous preterm birth (SPTB) in singleton gestations with prior SPTB. The aim of this systematic review and meta-analysis was to evaluate the efficacy of vaginal progesterone compared with 17-OHPC in prevention of SPTB in singleton gestations with prior SPTB. Methods Searches of electronic databases were performed to identify all RCTs of asymptomatic singleton gestations with prior SPTB that were randomized to prophylactic treatment with either vaginal progesterone (intervention group) or intramuscular 17-OHPC (comparison group). No restrictions for language or geographic location were applied. The primary outcome was SPTB < 34 weeks. Secondary outcomes were SPTB < 37 weeks, < 32 weeks, < 28 weeks and < 24 weeks, maternal adverse drug reaction and neonatal outcomes. The summary measures were reported as relative risk (RR) with 95% CI. Risk of bias for each included study was assessed. Results Three RCTs (680 women) were included. The mean gestational age at randomization was about 16 weeks. Women were given progesterone until 36 weeks or delivery. Regarding vaginal progesterone, one study used 90 mg gel daily, one used 100 mg suppository daily and one used 200 mg suppository daily. All included RCTs used 250 mg intramuscular 17-OHPC weekly in the comparison group. Women who received vaginal
Lancet (London, England), 2016
Progesterone administration has been shown to reduce the risk of preterm birth and neonatal morbidity in women at high risk, but there is uncertainty about longer term effects on the child. We did a double-blind, randomised, placebo-controlled trial of vaginal progesterone, 200 mg daily taken from 22-24 to 34 weeks of gestation, on pregnancy and infant outcomes in women at risk of preterm birth (because of previous spontaneous birth at ≤34 weeks and 0 days of gestation, or a cervical length ≤25 mm, or because of a positive fetal fibronectin test combined with other clinical risk factors for preterm birth [any one of a history in a previous pregnancy of preterm birth, second trimester loss, preterm premature fetal membrane rupture, or a history of a cervical procedure to treat abnormal smears]). The objective of the study was to determine whether vaginal progesterone prophylaxis given to reduce the risk of preterm birth affects neonatal and childhood outcomes. We defined three primar...
Does Progesterone Treatment Influence Risk Factors for Recurrent Preterm Delivery?
Obstetrics & Gynecology, 2005
Objective: To examine how demographic and pregnancy characteristics can affect the risk of recurrent preterm delivery and the how the effectiveness of progesterone treatment for prevention alters these relationships. Methods: This was a secondary analysis of a randomized trial of 17␣-hydroxyprogesterone caproate to prevent recurrent preterm delivery in women at risk. Associations of risk factors for preterm delivery (less than 37 completed weeks of gestation) were examined separately for the women in the 17␣-hydroxyprogesterone caproate (n ϭ 310) and placebo (n ϭ 153) groups. Results: Univariate analysis found that the number of previous preterm deliveries and whether the penultimate delivery was preterm were significant risk factors for preterm delivery in both the placebo and progesterone groups. High body mass index was protective of preterm birth in the placebo group. Multivariate analysis found progesterone treatment to cancel the risk of more than 1 previous preterm delivery, but not the risk associated with the penultimate pregnancy delivered preterm. Obesity was associated with lower risk for preterm delivery in the placebo group but not in the women treated with progesterone.
American Journal of Obstetrics and Gynecology, 2003
Recent studies have shown that an increase in the number of uterine contractions precedes the onset of preterm labor, and the frequency of uterine contractions in pregnancies with preterm delivery is higher than in women with term and postterm delivery. Progesterone is useful in allowing pregnancy to reach its physiologic term because at sufficient levels in the myo-OBJECTIVE: The purpose of this study was to evaluate the effect of prophylactic vaginal progesterone in decreasing preterm birth rate in a high-risk population. STUDY DESIGN: A randomized, double-blind, placebo-controlled study included 142 high-risk singleton pregnancies. Progesterone (100 mg) or placebo was administered daily by vaginal suppository and all patients underwent uterine contraction monitoring with an external tocodynamometer once a week for 60 minutes, between 24 and 34 weeks of gestation. Progesterone (n = 72) and placebo (n = 70) groups were compared for epidemiologic characteristics, uterine contraction frequency, and incidence of preterm birth. Data were compared by χ 2 analysis and Fisher exact test. RESULTS: The preterm birth rate was 21.1% (30/142). Differences in uterine activity were found between the progesterone and placebo groups (23.6% vs 54.3%, respectively; P < .05) and in preterm birth between progesterone and placebo (13.8% vs 28.5%, respectively; P < .05). More women were delivered before 34 weeks in the placebo group (18.5%) than in the progesterone group (2.7%) (P < .05). CONCLUSION: Prophylactic vaginal progesterone reduced the frequency of uterine contractions and the rate of preterm delivery in women at high risk for prematurity. (Am J Obstet Gynecol 2003;188:419-24.)