A systematic review and meta‐analysis of randomized controlled trials comparing 17‐alpha‐hydroxyprogesterone caproate versus placebo for the prevention of recurrent preterm birth

Fernández-Macías, Rosa; Martinez‐Portilla, R.J.; Cerrillos, Lucas; Figueras, F.; Palacio, Montse

doi:10.1002/ijgo.12940

Cited by 23 publications

(21 citation statements)

References 37 publications

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“…It is recommended for women with a history of PTD to receive more intensive prenatal monitoring, including treatment strategies to reduce PTD risk. Often weekly mid-trimester 17-alpha-hydroxyprogesterone caproate (17-OHPC) are applied to reduce risk for PTD recurrence [ 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

Can We Predict Preterm Delivery Based on the Previous Pregnancy?

Wainstock

Sergienko

2021

JCM

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(1) Background: Preterm deliveries (PTD, <37 gestational weeks) which occur in 5–18% of deliveries across the world, are associated with immediate and long-term offspring morbidity, as well as high costs to health systems. Our aim was to identify risk factors during the first pregnancy ending at term for PTD in the subsequent pregnancy. (2) Methods: A retrospective population- based nested case−control study was conducted, including all women with two first singleton consecutive deliveries. Women with PTD in the first pregnancy were excluded. Characteristics and complications of the first pregnancy were compared among cases, defined as women with PTD in their second pregnancy, and the controls, defined as women delivering at term in their second pregnancy. A multivariable logistic regression model was used to study the association between pregnancy complications (in the first pregnancy) and PTD (in the subsequent pregnancy), while adjusting for maternal age and the interpregnancy interval. (3) Results: A total of 39,780 women were included in the study, 5.2% (n = 2088) had PTD in their second pregnancy. Women with PTD, as compared to controls (i.e., delivered at term in second pregnancy), were more likely to have the following complications in their first pregnancy: perinatal mortality (0.4% vs. 1.0%), small for gestational age (12.4% vs. 8.1%), and preeclampsia (7.6% vs. 5.7%). In the multivariable model, after adjusting for maternal age, interpregnancy interval and co-morbidities, having any one of these first pregnancy complications was independently associated with an increased risk for PTD (adjusted OR = 1.44; 95%CI 1.28–1.62), and the risk was greater if two or more complications were diagnosed (adjusted OR = 2.09; 95%CI 1.47–3.00). These complications were also risk factors for early PTD (<34 gestational weeks), PTD with a systematic infectious disease in the background, and possibly with spontaneous PTD. (4) Conclusions: First pregnancy complications are associated with an increased risk for PTD in the subsequent pregnancy. First pregnancy, although ending at term, may serve as a window of opportunity to identify women at risk for future PTD.

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Section: Introductionmentioning

confidence: 99%

Can We Predict Preterm Delivery Based on the Previous Pregnancy?

Wainstock

Sergienko

2021

JCM

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“…Intramuscular progestin therapy was effective in preventing PTB in women with a history of PTB in some studies, 5,17,36 but not in women with short CL 37,38 . In contrast to IM progestin therapy, vaginal progesterone therapy has been shown to be effective in preventing PTB both in women with history of spontaneous PTB and in women with short CL in many randomised trials, 19,20,22,39,40 but not in all 23 .…”

Section: Discussionmentioning

confidence: 99%

“…Progestogens are available in natural micronised or synthetic formulations for intramuscular, vaginal (tablet or gel) or oral administration 14 . Previous studies have reported that the injection of 17α‐hydroxyprogesterone caproate (17‐OHPC) can reduce recurrent PTB in women with a previous history of PTB 15–17 . Vaginal micronised natural progesterone therapy has also been found to be effective in preventing PTB in women with a history of PTB or with short CL in many trials, 18–22 but not in all 23 .…”

Section: Introductionmentioning

confidence: 99%

Vaginal compared with intramuscular progestogen for preventing preterm birth in high‐risk pregnant women (VICTORIA study): a multicentre, open‐label randomised trial and meta‐analysis

Choi

Kwak

Kil

et al. 2020

BJOG

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Objective To compare the efficacy of two types of progestogen therapy for preventing preterm birth (PTB) and to review the relevant literature. Design A multicentre, randomised, open‐label, equivalence trial and a meta‐analysis. Setting Tertiary referral hospitals in South Korea. Population Pregnant women with a history of spontaneous PTB or short cervical length (<25 mm). Methods Eligible women were screened and randomised at 16‒22 weeks of gestation to receive either 200 mg of vaginal micronised progesterone daily (vaginal group) or an intramuscular injection of 250 mg 17α‐hydroxyprogesterone caproate weekly (IM group). Stratified randomisation was carried out according to participating centres and indications for progestogen therapy. This trial was registered at https://ClinicalTrials.gov (NCT02304237). Main outcome measure Preterm birth (PTB) before 37 weeks of gestation. Results A total of 266 women were randomly assigned and a total of 247 women (119 and 128 women in the vaginal and IM groups, respectively) were available for the intention‐to‐treat analysis. Risks of PTB before 37 weeks of gestation did not significantly differ between the two groups (22.7 versus 25.8%, P = 0.571). The difference in PTB risk between the two groups was 3.1% (95% CI −7.6 to 13.8%), which was within the equivalence margin of 15%. The meta‐analysis results showed no significant differences in the risk of PTB between the vaginal and IM progestogen treatments. Conclusion Compared with vaginal progesterone, treatment with intramuscular progestin might increase the risk of PTB before 37 weeks of gestation by as much as 13.8%, or reduce the risk by as much as 7.6%, in women with a history of spontaneous PTB or with short cervical length. Tweetable abstract Vaginal and intramuscular progestogen showed equivalent efficacy for preventing preterm birth before 37 weeks of gestation.

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“…Fuchs et al 10 pointed out that bed rest, preventive oral inhibitors of uterine contraction, progesterone, preventive cervical cerclage and other methods were common prevention for PTB, but there was no evidence that they could reduce the risk of PTB. Fernandez-Macias et al 11 found that 17-alphahydroxyprogesterone caproate (17-OHPC) got a 29%, 26%, 40% reduction in recurrent PTB at < 37, <35, and < 32 gestational weeks respectively, also 68% reduction in neonatal death (95%CI: 0.15-0.66, P = 0.002).…”

Section: Validation Of Scoring Systemmentioning

confidence: 99%

Early Prediction Model for Preterm Birth Combining Demographic Characteristics and Clinical Characteristics

Chen

Xie

Liang

et al. 2020

Preprint

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Objective. To create early prediction models for preterm birth (PTB) based on the Chinese population, combining demographic characteristics and clinical characteristics.Methods. A retrospective study on 15197 pregnant women who were recruited in Obstetrics and Gynecology Hospital of Zhejiang University from January1, 2017 to December 31, 2017. Demographic characteristics and clinical characteristics were collected and were randomly divided into the observation group (80%) and the validation group (20%). Multivariable Logistics regression analysis was performed to develop a risk prediction model in the observation group and the validation group. It was evaluated by the value of area under the curve (AUC) of receiver operating characteristic (ROC). Finally, we got a simple scoring system to present the preterm birth risk. Results. There were 1082 pregnant women (8.9%) developed PTB in the observation group and 316 pregnant women (10.3%) in the validation group. Gravidity, educational level, residence, previous history of PTB, twin pregnancy, pre-gestational diabetes mellitus (type I or II), chronic hypertension, placenta previa, gestational hypertension were significant predictors of future PTB. These factors were all included in the model, the AUC was 0.746 with sensitivity of 61.4% (95%CI: 61.4-66.7%) and specificity of 86.6% (95%CI: 85.2-87.9%) at the threshold score of 8.Conclusion. PTB can be predicted by demographic characteristics and clinical characteristics pre-pregnancy or during pregnancy, thus predicting and preventing PTB as early as possible.

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A systematic review and meta‐analysis of randomized controlled trials comparing 17‐alpha‐hydroxyprogesterone caproate versus placebo for the prevention of recurrent preterm birth

Cited by 23 publications

References 37 publications

Can We Predict Preterm Delivery Based on the Previous Pregnancy?

Can We Predict Preterm Delivery Based on the Previous Pregnancy?

Vaginal compared with intramuscular progestogen for preventing preterm birth in high‐risk pregnant women (VICTORIA study): a multicentre, open‐label randomised trial and meta‐analysis

Early Prediction Model for Preterm Birth Combining Demographic Characteristics and Clinical Characteristics

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