Vaginal progesterone is an alternative to cervical cerclage in women with a short cervix and a history of preterm birth

OBJECTIVE: The present study aimed to evaluate the effect of vaginal progesterone administration on maternal and fetal circulation to prevent preterm birth.METHODS: The present prospective study was conducted on 35 women with singleton pregnancy at 18–33 weeks of gestation, who presented with at least one episode of preterm labor or asymptomatic short cervix, or past medical history of preterm birth. Doppler flow and Pulsatility Index (PI) assessment of the umbilical artery, fetal middle cerebral artery, uterine arteries, and ductusvenosus were performed before and 72 h after vaginal progesterone administration.RESULTS: Results showed a significant reduction in the PI of the uterine artery following progesterone administration. Nevertheless, no significant changes were observed in the PI of other vessels. No significant difference was found in Doppler flow parameters in any of the examined vessels before or after progesterone treatment in women with Preterm Labor Pain (PLP). Yet, a statistically significant association was observed between short cervix complication in the current pregnancy and medical history of PLP in the previous pregnancy.CONCLUSION: Treatment with vaginal progesterone reduced the PI in the uterine arteries in the second and third trimesters of pregnancy. Thus, this medication may have useful vasodilatory effects on uterine-fetal vessels.

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Effectiveness of combined vaginal progesterone and cervical cerclage in preventing preterm birth: a systematic review and meta-analysis protocol

BMJ Open ◽

10.1136/bmjopen-2021-050086 ◽

2021 ◽

Vol 11 (6) ◽

pp. e050086

Author(s):

Rosanna C Diacci ◽

Ashad Issah ◽

Kimberley P Williams ◽

Liam McAuliffe ◽

Anne-Marie Aubin ◽

...

Keyword(s):

Preterm Birth ◽

Fixed Effects ◽

Combined Therapy ◽

Combined Treatment ◽

Cochrane Library ◽

Publication Date ◽

Singleton Pregnancy ◽

Cervical Cerclage ◽

Short Cervix ◽

Vaginal Progesterone

IntroductionPreterm birth (PTB) is the leading cause of death in children under 5 years. Preventive therapies targeted towards women with risk factors such as a prior PTB or a short cervix reduce the rate of PTB. Cervical cerclage, vaginal progesterone and a combination of the two have been used with no consensus as to whether combined treatment is more effective than any single treatment alone. The objective of this review is to determine the efficacy of combined treatment compared with cerclage alone and combined treatment compared with progesterone alone.Methods and analysisStudies will be sourced from the electronic databases Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Scopus, CINAHL (EBSCOhost) and Cochrane Library (Wiley) and reference lists. We will not exclude any papers due to publication date. Randomised control trials (RCTs), non-RCTs and cohort studies assessing single therapy (either progesterone or cerclage) versus combined therapy in women with a singleton pregnancy will be included. Two independent reviewers will conduct study screening (at abstract and full-text level), data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. Random or fixed effects models will be used depending on data heterogeneity and data will be presented as risk ratio for dichotomous data or mean difference for continuous data with a CI of 95% used for all outcomes.Ethics and disseminationNot applicable due to nature of the study type.PROSPERO registration numberCRD42020195975.

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Vaginal Progesterone Is as Effective as Cervical Cerclage to Prevent Preterm Birth in Women With a Singleton Gestation, Previous Spontaneous Preterm Birth, and a Short Cervix

Obstetrical & Gynecological Survey ◽

10.1097/01.ogx.0000549662.24782.f0 ◽

2018 ◽

Vol 73 (12) ◽

pp. 674-676

Author(s):

Agustin Conde-Agudelo ◽

Roberto Romero ◽

Eduardo Da Fonseca ◽

John M. OʼBrien ◽

Elcin Cetingoz ◽

...

Keyword(s):

Preterm Birth ◽

Spontaneous Preterm Birth ◽

Cervical Cerclage ◽

Short Cervix ◽

Vaginal Progesterone

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Re: Vaginal progesterone, cerclage or cervical pessary for preventing preterm birth in asymptomatic singleton pregnant women with history of preterm birth and a sonographic short cervix. Z. Alfirevic, J. Owen, E. Carreras Moratonas, A. N. Sharp, J. M. Szy

Ultrasound in Obstetrics and Gynecology ◽

10.1002/uog.12398 ◽

2013 ◽

Vol 41 (2) ◽

pp. 130-130 ◽

Cited By ~ 1

Author(s):

G. Makrydimas

Keyword(s):

Preterm Birth ◽

Pregnant Women ◽

Short Cervix ◽

Cervical Pessary ◽

Vaginal Progesterone ◽

History Of

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Rationale and design of SuPPoRT: a multi-centre randomised controlled trial to compare three treatments: cervical cerclage, cervical pessary and vaginal progesterone, for the prevention of preterm birth in women who develop a short cervix

BMC Pregnancy and Childbirth ◽

10.1186/s12884-016-1148-9 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 17

Author(s):

Natasha L. Hezelgrave ◽

Helena A. Watson ◽

Alexandra Ridout ◽

Falak Diab ◽

Paul T Seed ◽

...

Keyword(s):

Preterm Birth ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cervical Cerclage ◽

Short Cervix ◽

Cervical Pessary ◽

Vaginal Progesterone ◽

Randomised Controlled

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Cervical Cerclage versus Vaginal Progesterone for Management of Short Cervix in Low-Risk Women

American Journal of Perinatology ◽

10.1055/s-0038-1668547 ◽

2018 ◽

Vol 36 (02) ◽

pp. 111-117 ◽

Cited By ~ 1

Author(s):

Sarah Dotters-Katz ◽

Brenna Hughes ◽

Amber Wood

Keyword(s):

Preterm Birth ◽

Transvaginal Ultrasound ◽

Cervical Length ◽

Low Risk ◽

Prior History ◽

Short Cervix ◽

Vaginal Progesterone ◽

History Of ◽

Secondary Outcomes ◽

Low Risk Women

Objective To evaluate the risk of preterm birth in low-risk women with cervical length (CL) ≤25 mm on transvaginal ultrasound (TVUS) managed with vaginal progesterone (VagP) therapy versus cerclage. Study Design This is a retrospective cohort of women with no prior history of preterm birth or cervical insufficiency and CL ≤ 25 mm on TVUS, managed with either VagP therapy alone or cerclage (with or without VagP). The primary outcome was rate of preterm delivery < 37 weeks gestational age (GA). Secondary outcomes included delivery at ≤ 32 or ≤ 28 weeks GA, premature preterm rupture of membranes, pregnancy latency, GA at delivery, and composite neonatal outcome. Results Women undergoing cerclage placement (n = 31) were older and had an earlier GA at the time of diagnosis of short cervix compared with women receiving VagP (n = 62). Delivery at < 37 weeks occurred in 21/62 (33.9%) in the VagP group and 14/31 (45.2%) in the cerclage group (adjusted odds ratio: 1.72, 95% confidence interval: 0.52, 5.66). There were no differences in secondary outcomes. Conclusion Cerclage compared with VagP therapy did not decrease risk of preterm birth in women with CL ≤ 25 mm. Further research is needed to determine optimal management in such women given a residual 40% risk of preterm birth despite optimal therapy.

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Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2019-036587 ◽

2020 ◽

Vol 10 (6) ◽

pp. e036587

Author(s):

Vinh Q Dang ◽

Yen TN He ◽

Ha NH Pham ◽

Tuyen TT Trieu ◽

Trung Q Bui ◽

...

Keyword(s):

Clinical Trial ◽

Preterm Birth ◽

Randomised Clinical Trial ◽

Cervical Cerclage ◽

Short Cervix ◽

Cervical Pessary ◽

Vaginal Progesterone ◽

Increased Risk ◽

Patient Consent ◽

Twin Pregnancies

IntroductionWomen with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.Methods and analysisThis multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16–22 weeks’ gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks’ gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions.Ethics and disseminationEthical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT03863613 (date of registration: 4 March 2019).

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