What happened to Andrea Prudente and why the truth matters

It would be opportune to explain in lay terms exactly what happened in Andrea Prudente’s (AP) case and what risks she faced.

Essentially, her waters broke at around 15 weeks of pregnancy and she had no amniotic fluid (water) left at all. The technical term for this is pre-term, pre-labour, spontaneous (happens on its own) rupture of membranes, or PPROM for short. The management of this condition is one of the most difficult clinical situations in obstetrics.

PPROM before the fetus can survive on its own (under 23+6 weeks), is called pre-viable PPROM. It happens in about one in 200 pregnancies and significantly increases the risk of fetal death and serious illness in the newborn. PPROM can also cause serious harm to the pregnant person.

The purpose of this article is to summarise the scientific research that shows that the probability of survival of a 15-week-old fetus (as in the case of AP’s) is far less than the risk that the pregnant person would develop infection and/or bleeding, either of which put her life at risk.

In most of the studies, women were given the option of terminating a pregnancy without waiting, which is not the case currently in Malta. Because the majority of the most ill fetuses would have been terminated, the results summarised here very likely overestimate survival rates.

Because the probability of illness and death of the newborn decreases as the pregnancy advances, it is essential to separate outcomes according to the weeks of pregnancy at which PPROM happens. For example, let us take the first study that was widely discussed in the media after the first sitting of the AP case in court. This was a 2022 Israeli study of 94 births complicated by PPROM at 17 to 33 weeks. In the group of 24 pregnancies between 17-23 weeks (i.e., pre-viable PPROM), there were 5 deaths (between 17 and 22 weeks), and 19 survivors until hospital discharge (between 19 and 23 weeks). In other words, no fetus at 17-18 weeks survived to discharge. Unfortunately, the authors did not report the gestational age of each of the fetuses that died. There were three deaths in the second group of 27 fetuses between 22 and 27 weeks. The survival rate was even higher after 27 weeks. For some reason, the results of this study were incorrectly reported in court (and reflected in the media) as an overall survival of 79%. AP’s fetus was at 15 weeks when her waters broke. Based only on this study, her fetus would have had a zero chance of survival.

However, good science demands that we examine more studies because small numbers can bias the results. A 2020 Australian study looked at 130 cases of pre-viable PPROM under 24 weeks. The overall survival to discharge of all neonates was 38% but this figure hides the fact that among those with early PPROM (under 19+6 weeks), the survival was 12.2% compared with 43.8% in those between 20 and 24 weeks. The overall fetal death rate was 30%; but this increased to 58% in those under 20 weeks, compared with 17% in those between 20 and 24 weeks. Unfortunately, the authors do not specify the gestational ages of the fetuses that died, but it is clear that neonatal survival was extremely poor in the group with early PPROM. This is the group that AP would have fallen in.

Of even greater concern are the reported complications that these women developed: 55% had incomplete removal of the pregnancy and placenta necessitating further treatment, 25% had bleeding, and 15% had infection. These results are consistent with those of a meta-analysis in 2009 of 14 studies of PPROM at the limits of viability clearly showing that in pre-viable PPROM, the probability of survival of a fetus under 20 weeks is far less than the risk of maternal complications.     

This brings us to an Irish study in 2016 of 42 cases of pre-viable PPROM between 14 and 23+6 weeks. This study was carried out at a time when the circumstances in Ireland were identical to the current situation in Malta with a blanket ban on abortion. 32 fetuses (76%) died either in utero, or during or at birth. The remaining ten were born alive with a mean gestational age at birth of 25+5 (range 23+3 to 29+4) weeks. None of the 11 infants born under 17 weeks survived; three of 17 born between 17 and 21+6 weeks survived (of whom one died within 24 hours); seven of the nine  born after 22 weeks survived. As in the previous study the risk of maternal complications was high. For example, 67% had evidence of infection, 38% needed intravenous antibiotics, 21% had a retained placenta requiring surgery, 12% had heavy bleeding, and 7% needed a blood transfusion.

So had AP been part of this study, given that her fetus was at 15 weeks when she was first admitted to hospital, her fetus would have been among those that did not survive and her risk of complications would have been as listed above.

In a study conducted in Germany of 101 pregnancies under 24 weeks, one third opted to terminate their pregnancy because the amount of water around the fetus was very reduced or absent (as in the case of AP). Of the remaining pregnancies, 42% miscarried before 24 weeks. The authors do not provide any details on the earliest PPROM gestation with a live outcome. Because this study included the option of terminating a pregnancy without waiting, which is not the case currently in Malta, the results very likely overestimate survival rates.

The 2018 study of 104 singleton pregnancies conducted in Spain showed that no fetus with PPROM at less than 18.3 weeks survived. Fetal survival was much poorer when there was little to no amniotic fluid left over. This is especially so if this persists, as it did in the case of AP, probably because the lack of water around the pregnancy interferes with lung development.

Except after amniocentesis, the re-sealing of membranes in spontaneous PPROM is rare (estimated at 2.8% - 13%). This is especially so if the re-sealing does not happen within a few days of the waters breaking (as in the case of AP).

In conclusion, in none of the studies summarised here, did any fetus under 18 weeks survive to discharge from hospital. Moreover, there are significant risks to the newborn if born alive, including breathing complications and bleeding into the brain, among others, all of which can affect long-term well-being.

It is precisely for these reasons that women presenting with PPROM before or around the time of neonatal viability should be counseled regarding the risks and benefits of a wait-and-see approach, compared with immediate delivery. Counseling should include a realistic appraisal of neonatal outcomes. International guidelines support the option of offering immediate delivery.

Andrea Prudente should have been offered this option. Instead, her doctors waited and waited for her to get ill enough to decide between her life and that of her fetus. Meanwhile she ran the risk of life-threatening complications. Bill 28 will put paid to this.