ARRIVE trial results - elective induction of labor at 39 weeks

labordude, BSN, RN · Aug 11, 2018

This is not as clear cut as the researchers would like it to be. I am curious to see the detailed analyses that often come out from independent statisticians because I definitely have questions. One of my friends worked in one of their sites and said that they went to extraordinary lengths to get a lady partsl delivery at all costs while treating these pregnant patients like science experiments.

queenanneslace, ADN, MSN, APRN, CNM · Aug 11, 2018

Thanks. I'd love to hear more of your questions.

As far as acheiving 'lady partsl delivery at all costs' do you believe this was an intervention employed in the experimental group (IOL at 39 weeks) versus the control group? Or do you believe both groups were subject to the same treatment? This trial occurred in something like 40 hospitals, do you believe what your friend experienced was true at every site?

It's true, it is hard to control for a lot of potentially confounding factors.

klone, MSN, RN · Aug 11, 2018

This is not as clear cut as the researchers would like it to be. I am curious to see the detailed analyses that often come out from independent statisticians because I definitely have questions. One of my friends worked in one of their sites and said that they went to extraordinary lengths to get a lady partsl delivery at all costs while treating these pregnant patients like science experiments.

I worked at one of the sites in perinatal research when this study first started recruiting (University of Colorado), and the research team has nothing to do with/no input on the patient's care. They enrolled them if they met the qualifications, followed their progress, and that's it. They are not involved in the decision-making for care decisions. That would be highly unethical.

Their care is no different than any other laboring patients. I would be interested in knowing what your friend perceived as "treating them like science experiments." Other than talking to them about the study and consenting them, the research group has nothing to do with the patient.

klone, MSN, RN · Aug 11, 2018

This trial occurred in something like 40 hospitals, do you believe what your friend experienced was true at every site?

I don't think it was that many hospitals. There are only about 6 or 8 NIH MFMU sites, and each site only recruits at one or two large hospitals, as far as I know.

I just looked it up, there are 12 MFMU sites, sorry.

klone, MSN, RN · Aug 11, 2018

My thoughts:

I have been battling with the OB providers at my small community hospital for 2 years regarding elective IOL. In my ideal world, we would not do elective IOLs at all. Where I came from in Denver, that was the policy. Once a woman was 41w0d they would consider induction for post-dates.

This has been a HUGE barrier, and the providers are adamantly opposed to the idea of not allowing elective IOLs. I was SLOWLY trying to get them on board with the idea of no social IOLs before 40 weeks, and only with a Bishop >7. Now that this study has been published, they're all gung-ho about scheduling them at 39w now.

I have to admit, I'm so tired of fighting them. I'm ready to say **** it.

**LibraSunCNM, BSN, MSN, CNM** · Aug 12, 2018

As a CNM working in a freestanding birth center, we do not plan on changing our practice in any way because of these results. My (limited so far, I haven't gotten a chance this week to dive deeply into it) understanding of the analysis is that the study participants were only women cared for by physicians in academic medical centers. As such, it's almost like comparing apples to oranges when trying to apply it to midwifery care, because the entire philosophy around midwifery care is to avoid a lot of the things that are routine in OB/GYN physicians' practice. True comparison of the risks/benefits of elective induction of labor, to me, would involve some comparison to women of equal risk in a much lower intervention setting than a hospital, such as a birth center or home.

I just can't understand how rational human beings can think that the process of labor and birth needs to be interfered with this drastically to provide better outcomes for moms and babies. If we truly want to make a difference in the disgustingly high rates of maternal and infant morbidity and mortality rates in this country, we should be looking to the practices of other countries who spend less and have better outcomes. This involves:

-midwifery care for all low risk women

-midwife/physician co-management for moderate risk women

-judicious use of interventions in labor and delivery

-robust postpartum support for mothers

-careful tracking of obstetric outcomes throughout the country with dedicated interdisciplinary groups who study poor outcomes and work together to find solutions

As a side note, a midwife I work with at my current job was working as an L&D nurse at one of the ARRIVE study hospitals a couple of years ago and did state that she personally witnessed a nurse researcher whose job it was to recruit participants for the study behaving in a grossly unethical manner, saying things like, "Come on, don't you want to meet your baby sooner?" to women who declined to participate, not taking no for an answer. Just one person's experience, but overall, I don't really take the results seriously for that, as well as the other reasons I mentioned above. What makes me sad is what klone described, that some MDs will truly apply this to their practice and start inducing all of their patients at 39 weeks. I try to keep my head down when crap like this pops up, maligning the idea that normal birth has a place in this world anymore, and know that I still believe in the midwifery model of care and will keep fighting for it.

**LibraSunCNM, BSN, MSN, CNM** · Aug 12, 2018

I just saw this on Facebook and thought it was pretty helpful:

ARRIVEinfographic.pdf

klone, MSN, RN · Aug 12, 2018

As a side note, a midwife I work with at my current job was working as an L&D nurse at one of the ARRIVE study hospitals a couple of years ago and did state that she personally witnessed a nurse researcher whose job it was to recruit participants for the study behaving in a grossly unethical manner, saying things like, "Come on, don't you want to meet your baby sooner?" to women who declined to participate, not taking no for an answer. .

I don't doubt it's happened, and I've seen it. But as someone who worked in medical research for a few years, I can say that this behavior is not okay, and should be reported. Coercion into medical research is illegal.

labordude, BSN, RN · Aug 12, 2018

I worked at one of the sites in perinatal research when this study first started recruiting (University of Colorado), and the research team has nothing to do with/no input on the patient's care. They enrolled them if they met the qualifications, followed their progress, and that's it. They are not involved in the decision-making for care decisions. That would be highly unethical.
Their care is no different than any other laboring patients. I would be interested in knowing what your friend perceived as "treating them like science experiments." Other than talking to them about the study and consenting them, the research group has nothing to do with the patient.

I will ask her for more information. From talking with her, it sounded more like this was reflective of the academic environment she was in and may have been a larger perception than just related to this study.

labordude, BSN, RN · Aug 12, 2018

Thanks. I'd love to hear more of your questions.
As far as acheiving 'lady partsl delivery at all costs' do you believe this was an intervention employed in the experimental group (IOL at 39 weeks) versus the control group? Or do you believe both groups were subject to the same treatment? This trial occurred in something like 40 hospitals, do you believe what your friend experienced was true at every site?
It's true, it is hard to control for a lot of potentially confounding factors.

I think my biggest question would be in comparing the data in a true like for like situation. This was looking at babies born to a mom induced now (39 wks) vs those left expectant until the week after but doesn't include babies born spontaneously during that week. When this was studied in the past, it has been shown to demonstrate increased rates of cesarean or less difference between the two. Also, they seemed to have a decent rate of hypertension in a low-risk population at 9% for induction and 14% for expectant group. While the ranges I've seen for nullips are 4-16%, they are generally showing closer to 5-6% of these moms that will develop hypertension. They were expected to adhere to SMFM protocol for labor arrest and not even call it active labor until 6cm. If my providers started using ARRIVE, there would be way more c-sections here because they wouldn't follow the protocol.

UrbanHealthRN, BSN, RN · Aug 12, 2018

The main birthing hospital in my area participated in this study. I didn't know about it until some of my postpartum home visiting clients told me they had participated in it, and I was very confused as to how IOL of 39 weeks in healthy, low-risk pregnancies could have any benefits. It all sounded very unnatural and meddlesome to me, personally. As for the questionable ethics of the study and/or researchers, as some of you have mentioned, here's how the hospital advertised the study to women (direct quote from their website- they haven't taken the info down yet):

In this study we are looking at the effects of induction of labor and outcomes for moms and babies at 39 weeks of pregnancy in comparison to moms who go into spontaneous labor or who have labor induced at a later time in pregnancy. Prior medical research has shown that being induced at 39 weeks improves your baby's outcome. While everyone agrees that unless medically indicated, women should not be delivered prior to 39 weeks, the exact best date for delivery of your infant is unclear. In this randomized trial, half of the women who participate will be randomized to induction at 39 weeks and the other half of the women will be randomized to expectant management (unless medically indicated).

Previous research shows that induction at 39 weeks improves infant outcomes, but the "exact best date for delivery" is unknown? Sounds a bit contradictory and leading to me.