Vaginal progesterone as maintenance treatment after an episode of preterm labour (<scp>PROMISE</scp>) study: a multicentre, double‐blind, randomised, placebo‐controlled trial

Palacio, Montse; Cobo, Teresa; Antolín, E.; Ramírez, Marcos; Cabrera, Francisco; Rosales, Francisco; Bartha, J. L.; Juan, M.; Marti, A; Orós, Daniel; Rodriguez, Angela C. Incollingo; Scazzocchio, Elena; Olivares, JM; Varea, Sara; Ríos, José; Gratacós, E.

doi:10.1111/1471-0528.13956

Cited by 25 publications

(24 citation statements)

References 43 publications

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“…Other issues related to pregnancy outcomes of women discharged after admission for threatened preterm labor, such as the lack of an effective maintenance treatment [28,29] or characteristics of the neonates finally delivered at term [30][31][32], are out of the scope of this study; indeed, they are still under debate and need further evaluation.…”

Section: Discussionmentioning

confidence: 99%

Uterine Cervical Length Measurement to Reduce Length of Stay in Patients Admitted for Threatened Preterm Labor: A Randomized Trial

et al. 2017

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Objective: To study whether knowledge of cervical length (CL) is useful in reducing the length of hospital stay in women admitted because of threatened preterm labor. Methods: We performed a single-center, parallel, randomized trial at the Hospital Clínic of Barcelona. Inclusion criteria were single pregnancy, gestational age (GA) between 24⁺⁰ and 35⁺⁶ weeks, Bishop score <6, no parturition within 24-48 h after admission, and no clinical signs of chorioamnionitis, vaginal bleeding, or nonreassuring fetal status. CL measurement was performed 24-48 h after admission. In the control group, the patient and the physician in charge were blinded. In the study group, this information was given; if CL was >25 mm, early discharge within 12-24 h from randomization was recommended. Length of hospital stay was the main outcome. Results: After randomization, 149 patients had complete follow-up (control group, n = 74; study group, n = 75). The mean (SD) length of stay was significantly shorter - 3.0 (2.2) vs. 4.0 (2.0) days (p = 0.004) - in the study group, with a higher proportion of women remaining hospitalized ≤3 days (relative risk [95% confidence interval] 0.43 [0.26-0.70]), with no differences in GA at delivery or preterm birth rate. Conclusions: Knowledge of CL in women admitted because of threatened preterm labor is useful in reducing length of stay, with no impact on GA at delivery or preterm birth rate.

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Section: Discussionmentioning

confidence: 99%

Uterine Cervical Length Measurement to Reduce Length of Stay in Patients Admitted for Threatened Preterm Labor: A Randomized Trial

et al. 2017

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“…Yet since no study directly compared the efficacy of 100 and 200 mg, there is no explicit evidence on which dosage has greater effect in preventing PTB. Vaginal progesterone suppository was dosed either 200 or 400 mg when used in twin pregnancies [ 28 29 30 31 ] or as a treatment after inhibition of preterm labor [ 32 33 34 35 36 ], but the optimal dose and its efficacy in twin pregnancies and preterm labor requires further evidence.…”

Section: Type Routes Dose and Interval Of Administrationmentioning

confidence: 99%

“…In a meta-analysis performed by Suhag et al [ 71 ], vaginal progesterone supplement therapy was associated with a lower rate of PTB, a longer GAD, and a lower rate of neonate sepsis. However, 2 large multicenter, randomized, double-blind, placebo-controlled trial randomized trials [ 35 36 ] showed that the maintenance treatment of 200 mg of daily vaginal progesterone suppository in women after an episode of arrested preterm labor did not significantly reduce the rates of PTB <37 and <34 weeks of gestation.…”

Section: Summary Of Previous Studies Based On the Indicationsmentioning

confidence: 99%

Use of progesterone supplement therapy for prevention of preterm birth: review of literatures

Choi

2017

Obstet Gynecol Sci

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Preterm birth (PTB) is one of the most common complications during pregnancy and it primarily accounts for neonatal mortality and numerous morbidities including long-term sequelae including cerebral palsy and developmental disability. The most effective treatment of PTB is prediction and prevention of its risks. Risk factors of PTB include history of PTB, short cervical length (CL), multiple pregnancies, ethnicity, smoking, uterine anomaly and history of curettage or cervical conization. Among these risk factors, history of PTB, and short CL are the most important predictive factors. Progesterone supplement therapy is one of the few proven effective methods to prevent PTB in women with history of spontaneous PTB and in women with short CL. There are 2 types of progesterone therapy currently used for prevention of PTB: weekly intramuscular injection of 17-alpha hydroxyprogesterone caproate and daily administration of natural micronized progesterone vaginal gel, vaginal suppository, or oral capsule. However, the efficacy of progesterone therapy to prevent PTB may vary depending on the administration route, form, dose of progesterone and indications for the treatment. This review aims to summarize the efficacy and safety of progesterone supplement therapy on prevention of PTB according to different indication, type, route, and dose of progesterone, based on the results of recent randomized trials and meta-analysis.

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“…Different biochemical markers are now available for research purposes not for routine clinical practice [10]. There are lots of controversies regarding the role of local progesterone in the arrest of threatened preterm delivery [11]. Some studies proved its anti-inflammatory and local cervical effects while others discussed its vasodilatory effects on fetomaternal circulations [9].…”

Section: Discussionmentioning

confidence: 99%

The Effect of Rectal Progesterone on Doppler Parameters of the Uterine Arteries for the Prevention of Preterm Delivery in Iraqi Population

Farhan¹,

Hameed²,

Zghair³

2018

Asian J Pharm Clin Res

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Objective: The effectiveness of progesterone in the prevention of threatened preterm labor has been established for many years, but the preferable route, dose, and duration of treatment are until now under the evaluation of researches. The aim of this study was to determine the effect of rectal progesterone on Doppler indices of the uterine arteries in pregnant women with threatened preterm delivery.Methods: A prospective case–control study was conducted at the obstetric ward and the Outpatients Department of Al-Yarmouk Teaching Hospital in Baghdad for the period of 1 year from April 1, 2017, to April 1, 2018. 100 women were enrolled in the study, 50 of them were pregnant women with a diagnosis of preterm labor assigned as a study group and the other 50 were apparently healthy pregnant women of the same gestational age assigned as a control group. Doppler study of uterine arteries was done to all participants, and the results were compared for both groups. The patients with preterm labor received nifedipine tocolysis initially until contractions subsided and Doppler study had been repeated for those women after 1 week of rectal progesterone therapy.Results: The study group had a significantly higher resistance index (RI) than the control group (0.58 vs. 0.52) as p<0.05, in spite of the pulsatility index (PI) being higher for the study group compared to the control group (0.78 vs. 0.77) but this difference was not statistically significant. The RI before the therapy (0.58) was significantly higher than the index after therapy (0.52), and the PI was again significantly higher before therapy (0.78) than after therapy (0.71) as p<0.05. During the follow-up period, 3 (6.5%), 4 (8.7), and 39 (84.8%) patients delivered within 1 week, after 1 week, and at term, respectively.Conclusion: Rectal progesterone can arrest threatened preterm labor, and this effect is possible in part explained by its action on uterine arteries.

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Vaginal progesterone as maintenance treatment after an episode of preterm labour (PROMISE) study: a multicentre, double‐blind, randomised, placebo‐controlled trial

Cited by 25 publications

References 43 publications

Uterine Cervical Length Measurement to Reduce Length of Stay in Patients Admitted for Threatened Preterm Labor: A Randomized Trial

Uterine Cervical Length Measurement to Reduce Length of Stay in Patients Admitted for Threatened Preterm Labor: A Randomized Trial

Use of progesterone supplement therapy for prevention of preterm birth: review of literatures

The Effect of Rectal Progesterone on Doppler Parameters of the Uterine Arteries for the Prevention of Preterm Delivery in Iraqi Population

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