As a mother would know, giving birth is an extremely painful ordeal, but once her child has entered the world, and the mother holds him or her for the first time, all of the suffering and anguish seems to dissipate. Unfortunately, this is not the case for all births. Every year, more than 500,000 babies (roughly 1 in 8) are born prematurely in the US alone, and the complications that arise from these cases can result in sustained suffering for both the child and mother.
Preterm birth (PTB) is considered to be any birth occurring before 37 weeks of gestation; the time an infant develops in the womb is normally 40 weeks gestation. PTB not only threatens an infant’s probability of survival, but is detrimental to his or her quality of life. Many premature babies suffer from mental retardation and physical disabilities such as cerebral palsy. In the occurrence of a PTB, doctors can only respond to the aftermath. In high risk patients, however, preventative methods are more effective, as they address the root of the problem before it occurs. The rationale behind PTB prevention is like spilt milk. If you remember to put away the carton, the milk will not spill.
As obstetricians Flood and Malone discuss in their seminar, prevention of PTB can be organized into two major categories: primary and secondary prevention. Primary prevention consists mainly of lifestyle habits that may reduce your risk of having a PTB, such as a balanced diet, while secondary prevention focuses on prolonging pregnancy in women who are at a higher risk of having a PTB. Higher risk women include those who have had a PTB previously or are pregnant with multiples (i.e. more than one baby at once). These patients are the focus of secondary prevention, patients like Nikki Fleming.
While working with one of her clients, social worker Nikki Fleming was overcome with what she can only describe as a “horrible pain.” Moments later, she noticed a discharge of fluid. She was confused and scared; it was January and her due date was in May. It was at the hospital that every mother’s worst nightmare became a reality for Nikki: she was in labor and already 2 centimeters dilated.
In 2004, Nikki Fleming gave birth to her first child, Lauren, 3.5 months early. Immediately, the newborn was rushed to the neonatal intensive care unit (NICU) where doctors worked quickly to assist her underdeveloped lungs, hooking her up to ventilators. It was probably in this setting, among the hubbub of emergency medicine, that Nikki first laid eyes on her baby, partially obscured by the myriad of tubes sustaining her fragile life.
Lauren remained in the NICU for 5 months. This is almost the same amount of time she spent in her mother’s womb. Today, she still suffers from asthma and has a learning impairment, problems common among those born prematurely.
Due to her history of PTB, Nikki now had a 25% higher chance of having a successive PTB. So, when she realized that she was pregnant again in 2011, she became a high risk patient, eligible for secondary prevention techniques. Cervical cerclage is one such technique that has been around for decades.
This physically intuitive surgery involves the stitching of the cervix shut to prevent PTB. The cervix is the passageway between the base of the uterus and the vagina through which an infant travels during birth. It is made of cartilage and normally is closed during pregnancy to prevent the baby from emerging from the uterus underdeveloped. However, in a PTB, the cervix is weak or abnormally short and does not function properly. Thus, stitching the cervix closed has become a widely accepted method of secondary prevention since the 1950s.
This procedure however, is still not well understood. Research demonstrates that the surgery is effective in high risk patients carrying a single child, but may encourage PTBs in patients carrying multiples. As with all secondary prevention methods, cervical cerclage is known to work in some instances but not in others.
A less invasive method is the injection of progesterone, a hormone that is produced naturally in the body and stimulates the strengthening of the fetal membrane. Unsurprisingly, the presence of progesterone decreases when women go into labor. As a result, researchers developed a synthetic version of the hormone that would strengthen the fetal membrane of women at high risk of a PTB. Such a treatment was prescribed to Nikki Fleming during her next pregnancy.
A synthetic progesterone-based hormone, 17P, had just been approved by the FDA that year when Nikki began her weekly injections and, though painful, proved to be successful, allowing her daughter, Erin, to be born one week shy of her due date. Unfortunately, this new method is estimated to prevent only 10,000 PTBs annually, which is just 2% of PTBs in the US. This is due to the fact that only certain types of high risk women are eligible for the treatment (e.g. woman pregnant with multiples are not eligible). This is where doctors get creative.
Medicine, like many professions, is heavily dependent upon trial and error and trying to fit the right pieces together to complete the puzzle and solve the problem. Such problem-solving requires “out of the box” thinking. This was beautifully demonstrated by the research team who identified a new and more effective method of secondary prevention: a combination of both 17P injections and cervical cerclage.
Recent findings presented at the American College of Obstetricians and Gynecologists’ (ACOG) Annual Clinical Meeting of 2013 showed this coupling of treatments to be a more effective method of preventing PTBs in extremely high risk patients. This discovery highlights the importance of innovative thinking in medical research. Such creativity will result in many more infants, like Erin, who will be given the opportunity to enter the world whole, but not all research generates an effective PTB prevention technique.
Some experimental drugs are never approved by the FDA as insufficient evidence supports their effectiveness and, in the case of relaxin (a protein-based hormone), some evidence exists to the contrary. Remember how medical research consists of trial and error?
Well, relaxin happens to be that error. This naturally occurring hormone regulates internal bodily functions during pregnancy and according to its designer, Dennis Stewart, relaxin strengthens the cervical membrane in women. However, a review of all relaxin experiments published by The Cochrane Library reveals that relaxin also has the potential to induce birth in some cases. Due to these mixed findings, none of the proposed benefits can be proven. Although not all research yields promising results, any attempt to provide these infants with a healthy start to life is worthwhile.
As a result of secondary prevention, Nikki has now successfully given birth to another child, her son Corbin, at 39 weeks. After the deep, heartfelt anguish that she and her husband experienced when their first child was born, this new research into synthetic progesterone injection prevented such complications from reoccurring. In this instance, the medical community successfully cared for the Flemings by identifying their need and developing a solution through whatever creative means necessary.
Nikki and her husband Densel have been chosen to be the 2011 ambassadors for March of Dimes, an organization devoted to the health of mothers and their babies. As ambassadors, the Flemings travel around the nation, telling their story and raising awareness for PTB and the possible methods of treatment. “We just hope through our travels that it gives people hope,” said Nikki, “We cry with families, we share with families [and] we talk about our experiences together,” and sometimes it is this small “injection” of hope that really is the best medicine.
The American College of Obstetricians and Gynecologists. (2013). 17P Plus Cerclage Decreases Preterm Labor Risk. Retrieved from http://www.acog.org/About-ACOG/News-Room/News-Releases/2013/17P-Plus-Cerclage-Decreases-Preterm-Labor-Risk
Bain E, Heatley E, Crowther CA, Hsu K, Wiley. 2013. Relaxin for preventing preterm birth (Review) The Cochrane Collaboration [Internet]. The Cochrane Collaboration [Internet]:1–12. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010073.pub2/pdf
Flood K, Malone FD, Elsevier. 2011. Prevention of preterm birth Seminars in Fetal and Neonatal Medicine [Internet]. Seminars in Fetal and Neonatal Medicine [Internet] Volume 17:59–61. Available from: http://www.sciencedirect.com/science/article/pii/S1744165X11000898
Stewart DR. 2011. Method of preventing premature delivery United States Patent Application Publication [Internet]. United States Patent Application Publication [Internet] 17:1–7, 12. Available from: https://docs.google.com/viewer?url=patentimages.storage.googleapis.com/pdfs/US20110166070.pdf
TIME Magazine. (2011). Prolonging Pregnancy: New Drug Helps Prevent Premature Birth. Retrieved from http://healthland.time.com/2011/02/08/prolonging-pregnancy-new-drug-helps-prevent-premature-birth/
U.S. News & World Report. 14-11/14. What You Can Do to Prevent Premature Birth [Internet]. Available from: http://health.usnews.com/health-news/patient-advice/articles/2014/11/14/what-you-can-do-to-prevent-premature-birth
WSOC-TV. 08-04/11. Family Focus: Family Raises Awareness About Premature Birth [Internet]. Available from: http://m.wsoctv.com/news/news/family-focus-family-raises-awareness-about-prematu/nGyzT/