Threatened Preterm Labour: responsible for 45% of global preterm deliveries

Threatened preterm labor.
Preemie Pride
Premature awareness month

Preterm delivery: WHO millennium-goal number IV

An estimated 15 million babies are born too early every year. That is more than 1 in 10 babies. Approximately 1 million children die each year due to complications of preterm birth (PB) [1]. Many survivors face a lifetime of disability, including learning disabilities and visual and hearing problems.Globally, prematurity is the leading cause of death in children under the age of 5 years. And in almost all countries with reliable data, preterm birth rates are increasing.

Inequalities in survival rates around the world are stark. In low-income settings, half of the babies born at or below 32 weeks (2 months early) die due to a lack of feasible, cost-effective care, such as warmth, breastfeeding support, and basic care for infections and breathing difficulties. In high-income countries, almost all of these babies survive. Suboptimal use of technology in middle-income settings is causing an increased burden of disability among preterm babies who survive the neonatal period.

More than 60% of preterm births occur in Africa and South Asia, but preterm birth is truly a global problem. In the lower-income countries, on average, 12% of babies are born too early compared with 9% in higher-income countries. Within countries, poorer families are at higher risk [1].

Threatened Preterm Labour: a huge social and health cost

Threatened Preterm Labour (TPL) is considered  the trigger for 45% of premature births, being rupture of membranes with 25%, and infections in the fetus or mother, present in 30% the other main sources of  PB [2].

TPL also represents one of the main causes of hospitalization during pregnancy, and several studies show that only in the US it  generates an associated economic burden of $820 million [3]. These economic numbers are not only due to the threats that eventually lead to a spontaneous premature delivery, but much of that cost is due to the hospitalization of false threats: only between 5% and 25% of the TPL leads to a spontaneous delivery in the following seven days after the event, and 40% of total threats will end in a birth on the date of natural birth [4,5]. On the other hand, between 33% and 42% of patients who have an initial TPL, a posteriori during the same pregnancy go to the emergency room with a new threat, which means a huge increasing in the cost associated with the problem.

Threatened Preterm Labour (TPL) is considered the trigger for 45% of premature births, being rupture of membranes with 25%, and infections in the fetus or mother, present in 30% the other main sources of PB #preterm… Click To Tweet

Although in last years some tools have appear as a solution for the diagnostic of false TPL, Clinical Protocols are not very clear about whether diagnostic tools are really worth it [8], and last Guidelines (i.e.  [6,7]) do not agree about the diagnostic test implementation. Cervical length (CL) measurement on its own (when CL < 15 mm) or CL + fFN test (when CL is between 16-30 mm and fFN test result is positive) in combination shown a really high sensitivity and specificity [9], but at the ends it looks like if it would be reduced into a test cost problem [10].

 

Measurement of the cervical length in combination with fibronectin test: how Threatened Preterm Labour is managed in Spain.

At Spanish clinical centers looks like it would be established how to procedure with TPL. When a pregnant woman between 24 and 35 weeks of gestation feels low back pain and contractions and goes to the emergency room, specialists directly procedure with a cervicometry. When the value CL is lower than 25 mm, a fibronectin test is performed to validate the diagnostic, which confirms or rules out the possibility of spontaneous premature delivery.

The reliability of both combined techniques is greater than 90%, but the process lasts approximately 2 hours (with the high uncertainty in that period of time for the pregnant woman and the specialist) and a cost per test of $225 [11]. It doesn’t look a big number, but it represents an associated cost for healthcare systems of more than $800 million per year in the US and Europe just for false TPL filtering process.

Innitius Point of View

It appears important to identify true TPL early in order to decrease neonatal morbidity and mortality, avoid maternal morbidity induced by antepartum bed rest and unnecessary treatment, and to reduce costs. But it is at least as important to establish a global way to proceeding which demonstrates not only a good accuracy at the diagnose, but also a good cost-effectiveness relation in order to implement it through the global health systems.

From Innitius, we are working on the Fine Birth with the aim of creating a new diagnostic tool for TPL filtering process. We bet for a tool available at each ultrasound-system, a technology able to diagnostic on real time spontaneous deliveries and without any additional cost per test for the center. Innitius truly believe on a new different clinical scene, where easy-to-use and cost-effectiveness make international guidelines think about recommending diagnostics tools for the improvement of Threatened Preterm Labour management.

Innitius bets for a tool available at each ultrasound-system, a technology able to diagnostic on real time spontaneous deliveries and without any additional cost per test for the center #preterm #prematurityawarenessmonth Click To Tweet

Bibliography

[1] World Health Organisation: http://www.who.int/news-room/fact-sheets/detail/preterm-birth . [2] Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008;371:75–84. [3] Nicholson WK, Frick KD, Powe NR. Economic burden of hospitalizations for preterm labor in the United States. Obstet Gynecol. 2000;96:95–101. [4] Sanchez-Ramos L, Delke I, Zamora J, Kaunitz AM. Fetal fibronectin as a short-term predictor of preterm birth in symptomatic patients: a metaanalysis.Obstet Gynecol. 2009;114:631–40. [5] McPheeters ML, Miller WC, Hartmann KE, Savitz DA, Kaufman JS, Garrett JM, et al. The epidemiology of threatened preterm labor: a prospective cohort study. Am J Obstet Gynecol. 2005;192:1325–9 (discussion 1329–1330). [6] Guidelines RCOG: Tocolysis for Women in Preterm Labour. Green–top Guideline February 2011, No. 1b. [7]. American College of Obstetrician and Gynecologists. Committee on Practice B-O: ACOG practice bulletin no. 127: Management of preterm labor. Obstet Gynecol. 2012;119:1308–17. [8] Sentilhes, L., Senat, M. V., Ancel, P. Y., Azria, E., Benoist, G., Blanc, J., … & Ducroux-Schouwey, C. (2016). Prevention of spontaneous preterm birth (excluding preterm premature rupture of membranes): Guidelines for clinical practice-Text of the Guidelines (short text). Journal de gynecologie, obstetrique et biologie de la reproduction, 45(10), 1446-1456. [9] Desplanches, T., Lejeune, C., Cottenet, J., Sagot, P., & Quantin, C. (2018). Cost-effectiveness of diagnostic tests for threatened preterm labor in singleton pregnancy in France. Cost Effectiveness and Resource Allocation, 16(1), 21. [10] American College of Obstetricians and Gynecologists. (2016). Practice Bulletin No. 171: Management of Preterm Labor. Obstetrics and gynecology, 128(4), e155.  [11] Sullivan, A., Hueppchen, N. A., & Satin, A. J. (2001). Cost effectiveness of bedside fetal fibronectin testing varies according to treatment algorithm. Journal of Maternal-Fetal Medicine, 10(6), 380-384.

Innitius, CEO.

I studied Building Engineering (BSc) and Structural Engineering (MSc) before recognizing the incredible opportunities Social Entrepreneurship could bring. I am a tech, health and business enthusiast dedicated to incorporating all areas in my life and business.

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