4-year Follow-Up Study of Children Exposed to 17P In Utero
Alix Boyle, OBGYN.net interviews Paul Meis, MD, Professor of Ob/Gyn, Wake Forest University, Winston-Salem, NC and Allison Northen, RN, University of Alabama at Birmingham, Birmingham, AL

read the abstract: 4-Year Follow-Up of Children Exposed to 17alpha Hydroxyprogesterone Caproate (17P) In Utero

Transcript

Alix Boyle: Hi, this is Alix Boyle for OBGYN.net. I am here with Paul Meis from Wake Forest University and Alison Northen from the University of Alabama at Birmingham. They are here to talk about their follow-up study on 17P. What is the title of your study?

Allison Northen, RN: The title of our study is a 4-Year Follow-Up of Children Exposed to 17 alpha Hydroxy Progesterone Caproate. This is a follow-up study of Dr Meis’ trial which I will let him tell you about.

Paul Meis, MD: Our study, which was presented four years ago and published four years ago, was a trial of a drug called 17 alpha hydroxy progesterone caproate or we just call it 17P. We studied this drug to see if it would reduce the risk of pre-term delivery in women who had had a previous pre-term delivery. These women were at high risk for having a pre-term baby. We showed in our study that the drug was effective in reducing the risk for these women and that the rate of pre-term delivery was reduced by about 33%. We were very pleased by this and the drug has received a lot of attention because this is really the first time that a drug has been shown to reduce the risk of pre-term delivery in women at high risk. The drug, however, has not been currently available from a pharmaceutical manufacturer and is available only from compounding pharmacies. A drug manufacturer has applied to the Food and Drug Administration to produce this drug for the indication of prevention of pre-term delivery. In the course of their application to the FDA, the FDA required that a follow-up study be performed on the children who were delivered from the women in this study, both the women who received the drug and the women who received a placebo. We were very pleased really that they requested this because we wanted to do this follow-up study from the beginning but did not have the resources to do so. The National Institute of Child Health and Human Development supported this follow-up study and Alison and her group performed this study and reported it today.

Alix Boyle: Alison, what was the size of the study?

Allison Northen, RN: Well, we were following the children in the randomized clinical trial. There were 459 in the original study. We were able to follow-up 80% of the children in the original trial. In the follow-up, we evaluated the children with the ages and stages questionnaire to look at developmental milestones and we did a physical exam and we also assessed the gender roles. Thank you, the gender roles in the children. We were basically looking at the safety of 17AHPC. We did not have the power to look at benefit in this trial but it was important that we looked at the safety for women who will be taking 17P in the future and those who have done it recently.

Alix Boyle: So were there any harmful effects noted in the study?

Allison Northen, RN: We did not notice any difference between the 17P exposed children versus the placebo children.

Paul Meis, MD: While there were no harmful effects seen, we could not definitely demonstrate that there was an advantage shown in these children born to the women who took the drug. However, to show such an advantage or difference in the two groups would require probably 1,000 children in each group and this study did not have the power to do that. So the importance of the study is that it is very reassuring concerning the safety of this drug.