Prevention and not merely prediction of preterm labor and delivery (original) (raw)

Effectiveness of a cervical pessary for women who did not deliver 48 h after threatened preterm labor (Assessment of perinatal outcome after specific treatment in early labor: Apostel VI trial)

BMC pregnancy and childbirth, 2016

Preterm birth is a major cause of neonatal mortality and morbidity. As preventive strategies are largely ineffective, threatened preterm labor is a frequent problem that affects approximately 10 % of pregnancies. In recent years, risk assessment in these women has incorporated cervical length measurement and fetal fibronectin testing, and this has improved the capacity to identify women at increased risk for delivery within 14 days. Despite these improvements, risk for preterm birth continues to be increased in women who did not deliver after an episode of threatened preterm labor, as indicated by a preterm birth rate between 30 to 60 % in this group of women. Currently no effective treatment is available. Studies on maintenance tocolysis and progesterone have shown ambiguous results. The pessary has not been evaluated in women with threatened preterm labor, however studies in asymptomatic women with a short cervix show reduced rates of preterm birth rates as well as perinatal compl...

Prevention of preterm birth among singleton pregnant women with an obtuse uterocervical angle: a quasi-experimental study on the value of cervical pessary combined with progesterone

Research Square (Research Square), 2024

Background: Micronized progesterone has been shown to be an effective preterm birth prophylactic intervention in singleton pregnancies with short cervical length measured via transvaginal ultrasound in the second trimester. The use of cervical pessary as a preventive method for preterm birth has limited research and controversial ndings when compared to progesterone-combining pessary, with the hypothesis that it narrows the uterocervical angle and reduces the risk of preterm birth. This study aimed to evaluate the value of cervical pessary combined with progesterone in the prevention of preterm birth among singleton pregnant women with a short cervix having uterocervical angles ≥95 o. Methods: A quasi-experimental study with a nonequivalent-group design was conducted on 225 singleton pregnant women with a gestational age of 16 +0-23 +6 weeks, having cervical length ≤25 mm. Participants were assigned into two groups: prophylactic treatment with progesterone alone or progesterone combined with a cervical pessary. The association between cervical length, uterocervical angle (≥95 o or ≥105 o), and preterm birth outcomes (<37 weeks or <34 weeks) was assessed by using a multivariable binary regression model. The difference was statistically signi cant with p <0.05. Results: The probability of preterm birth <37 weeks in the group of pregnant women with a uterocervical angle ≥95 o treated by progesterone plus cervical pessary decreased in comparison to the progesterone alone group, with an odds ratio (95% con dence interval) of 0.343 (0.147-0.801). In the group of pregnant women with a uterocervical angle ≥105 o , the treatment by a cervical pessary plus progesterone yielded a lower rate of preterm birth <37 weeks and <34 weeks, with an odds ratio (95% con dence interval) of 0.026 (0.005-0.132), and 0.084 (0.021-0.347), respectively. Conclusions: The results of this study suggested that a cervical pessary has an added effect combined with progesterone in preventing preterm birth among singleton pregnant women with obtuse uterocervical angles. The preventive effect is stronger if the uterocervical angle measurement is ≥105 o. BACKGROUND The World Health Organization de nes a preterm birth (PTB) as a live birth that takes place between 20 +0 and 36 +6 gestational weeks. An estimated 15 million babies are born prematurely each year worldwide, more than 60% of which occur in Africa and South Asia. According to UNICEF (2014), Vietnam's PTB rate was 9%, placing it 21 st globally. Although research efforts on PTB have been ongoing, PTB rates have remained unchanged over the past decade in every region of the world [1]. Two-thirds of PTBs are due to spontaneous preterm labor, which is still a challenge in obstetric care. This is a signi cant contributor to neonatal morbidity and death, primarily because of immature respiratory systems, brain bleeding, and infection. These conditions can result in long-term neurological abnormalities such as intellectual disability, cerebral palsy, chronic lung disease, deafness, and blindness [2]. Therefore, the effective and safe application of PTB preventive measures is clinically important.

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

BMC Pregnancy and Childbirth

Background Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. Methods This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 3...

A blueprint for the prevention of preterm birth: vaginal progesterone in women with a short cervix

Journal of Perinatal Medicine, 2000

Preterm birth is the leading cause of perinatal morbidity and mortality worldwide, and is the most important challenge to modern obstetrics. A major obstacle has been that preterm birth is treated (implicitly or explicitly) as a single condition. Two thirds of preterm births occur after the spontaneous onset of labor, and the remaining one third after " indicated " preterm birth; however, the causes of spontaneous preterm labor and " indicated " preterm birth are different. Spontaneous preterm birth is a syndrome caused by multiple etiologies, one of which is a decline in progesterone action, which induces cervical ripening. A sonographic short cervix (identifi ed in the midtrimester) is a powerful predictor of spontaneous preterm delivery. Randomized clinical trials and individual patient meta-analyses have shown that vaginal progesterone reduces the rate of preterm delivery at < 33 weeks of gestation by 44 % , along with the rate of admission to the neonatal intensive care unit, respiratory distress syndrome, requirement for mechanical ventilation, and composite neonatal morbidity/mortality score. There is no evidence that 17-α-hydroxyprogesterone caproate can reduce the rate of preterm delivery in women with a short cervix, and therefore, the compound of choice is natural progesterone (not the synthetic progestin). Routine assessment of the risk of preterm birth with cervical ultrasound coupled with vaginal progesterone for women with a short cervix is cost-effective, and the implementation of such a policy is urgently needed. Vaginal progesterone is as effective as cervical cerclage in reducing the rate of preterm delivery in women with a singleton gestation, history of preterm birth, and a short cervix (< 25 mm).

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial

BMC pregnancy and childbirth, 2017

Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, wil...

Pessary or progesterone to prevent preterm birth in women with short cervical length: protocol of the 4–6 year follow-up of a randomised controlled trial (Quadruple-P)

BMJ Open

IntroductionVaginal progesterone and a cervical pessary are both interventions that are investigated for the prevention of preterm birth (PTB). Thus far, beneficial or harmful effects of these interventions on long-term child health and development are described, but evidence is not robust enough to draw firm conclusions. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of PTB considering the child’s health at 4–6 years of corrected age.Methods and analysisThis study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of PTB. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4–6 years of corrected age. Children will be assess...

Prevention of preterm birth in women at risk: selected topics

2014

Participation in scientific or experimental research as an initiator, principal investigator or researcher: Chantelle Garritty; Laura Gaudet; Liesbeth Lewi (academic studies e.g. studies in monochorionic twins); Kristien Roelens, Geert Page Grants, fees or funds for a member of staff or another form of compensation for the execution of research: Wilfried Gyselaers (Promotor PHD's : IWT and LCRP-project at University Hasselt) Payments to speak, training remuneration, subsidised travel or payment for participation at a conference: Bart Van Overmeire (IPOKRaTES courses), Geert Page (lectures on EBM for LOK's; Urology congresses), Roland Van Dijck (participation congress) Presidency or accountable function within an institution, association, department or other entity on which the results of this report could have an impact: Anita Verhille (board member VVOC), Trinette Dirikx (board member VVOC), Yannic Verhaest (board member VVOC), Geert Page (member of VVOG) Other possible interests that could lead to a potential or actual conflict of interest: Anita Verhille, Trinette Dirikx, Yannic Verhaest Further, it should be noted that all experts and stakeholders, as well as the validators consulted within this report were selected because of their expertise in the field of preterm birth. Therefore, by definition, all consulted experts, stakeholders and validators have a certain degree of conflict of interest to the main topic of this report. Further, it should be noted that all experts and stakeholders, as well as the validators consulted within this report were selected because of their expertise in the field of preterm birth. Therefore, by definition, all consulted experts, stakeholders and validators have a certain degree of conflict of interest to the main topic of this report. Layout: Ine Verhulst Disclaimer: The external experts were consulted about a (preliminary) version of the scientific report. Their comments were discussed during meetings. They did not co-author the scientific report and did not necessarily agree with its content. Subsequently, a (final) version was submitted to the validators. The validation of the report results from a consensus or a voting process between the validators. The validators did not co-author the scientific report and did not necessarily all three agree with its content. Finally, this report has been approved by common assent by the Executive Board. Only the KCE is responsible for errors or omissions that could persist. The policy recommendations are also under the full responsibility of the KCE.