We are reporting here on a clinical trial that took place from 2019 to 2022. The objective of the trial was to fill a crucial evidence gap on the timing of a planned birth in cases with pre-eclampsia. Defined as “new onset” hypertension after 20 weeks of pregnancy, pre-eclampsia is extremely dangerous to both mother and infant. This trial sought to determine whether earlier delivery of the infant made a difference in the outcomes for mother and child. This trial took place in four sites in India and five sites in Zambia, all at hospitals that were higher level referral or tertiary facilities. There were 584 women involved in the study. Across these nine sites, investigators enrolled pregnant women with a pre-eclampsia diagnosis and a pregnancy at 34 to 36 weeks. They sought to compare the current practice, expectant management with an alternative, a planned delivery between 34 and 36 weeks. This was the first study to specifically examine the planned delivery option in a low-income or middle-income country. (for details on the study protocol please see the original article). For those women in the ‘planned delivery’ category, delivery was initiated within 48 hours of being randomized into the study. The study did not find statistically significant differences between the mothers in the ‘planned delivery’ category versus the ‘expectant management.’ The study found a They did, however, find significant differences in stillbirths. No stillbirths occurred in the intervention group (planned delivery) while ten stillbirths occurred in the ‘expectant management’ group, the group following the current guidelines at the time. There were also no differences in short-term neonatal complications between the two groups. In sum, this interesting clinical trial with 584 women had very promising results showing stillbirths were fewer (zero) with the intervention called ‘planned delivery.’ None of this information constitutes medical advice. Rather we are reporting on an important study for determining solutions to maternal and neonatal morbidity and mortality due to pre-eclampsia. Full study is published in The Lancet, June 29 2023
We are reporting here on a clinical trial that took place from 2019 to 2022. The objective of the trial was to fill a crucial evidence gap on the timing of a planned birth in cases with pre-eclampsia. Defined as “new onset” hypertension after 20 weeks of pregnancy, pre-eclampsia is extremely dangerous to both mother and infant.
This trial sought to determine whether earlier delivery of the infant made a difference in the outcomes for mother and child.
This trial took place in four sites in India and five sites in Zambia, all at hospitals that were higher level referral or tertiary facilities. There were 584 women involved in the study.
Across these nine sites, investigators enrolled pregnant women with a pre-eclampsia diagnosis and a pregnancy at 34 to 36 weeks. They sought to compare the current practice, expectant management with an alternative, a planned delivery between 34 and 36 weeks. This was the first study to specifically examine the planned delivery option in a low-income or middle-income country. (for details on the study protocol please see the original article).
For those women in the ‘planned delivery’ category, delivery was initiated within 48 hours of being randomized into the study.
The study did not find statistically significant differences between the mothers in the ‘planned delivery’ category versus the ‘expectant management.’ The study found a They did, however, find significant differences in stillbirths. No stillbirths occurred in the intervention group (planned delivery) while ten stillbirths occurred in the ‘expectant management’ group, the group following the current guidelines at the time. There were also no differences in short-term neonatal complications between the two groups.
In sum, this interesting clinical trial with 584 women had very promising results showing stillbirths were fewer (zero) with the intervention called ‘planned delivery.’ None of this information constitutes medical advice. Rather we are reporting on an important study for determining solutions to maternal and neonatal morbidity and mortality due to pre-eclampsia.
Full study is published in The Lancet, June 29 2023
