35. The Episiotomy Trial
After the surgery, Bonnie was still quadriplegic, on a respirator and locked in, meaning she could only communicate with eye blinks. We did not know if she would recover, or, if she did, what deficits she would have.
The phone rang at the Brennans’. It was Health Canada. I had forgotten that I had even applied for funding for a study of episiotomy.
“Why have you not responded to the reviewers?” challenged the administrator. I explained the circumstances. I was no longer even interested in doing the study. In fact, I explained, there was no way that I could convince the reviewers of the benefits of the study. These reviewers were overwhelmingly negative, expressing bizarre and misogynist views. The Health Canada staff member repeated: “Answer the reviewers.”
Finally, it dawned on me. Health Canada was prepared to dismiss the reviewers’ inappropriate assessments and fund the study. So I had a great time addressing the reviewers’ comments, letting it all hang out and telling them exactly what I thought of their reviews. It was deeply therapeutic for me at a time when I was preoccupied with Bonnie’s health. Health Canada gave me everything I asked for. In retrospect, I should have asked for more money. I managed to finish the study only because of the financial help from the McGill dean of medicine Dr. Richard Cruess, who felt the study was so important that he dipped into his private dean’s fund to support it.
Although I had been funded to carry out the trial, because of Bonnie’s illness, I was too distracted to actually conduct the trial for about a year after her strokes. The trial involved three Montreal hospitals and showed that episiotomy caused the very trauma it was supposed to be preventing, and that even spontaneous tears are less painful and heal better than episiotomy. The trial is credited with contributing to a dramatic drop in routine use of episiotomy worldwide. Before our study, episiotomy rates in Canada and the US were about 65 per cent, and severe tearing to the perineum was approximately 4.5 per cent. After the trial, episiotomy rates fell as low as 12 per cent, and severe tearing dropped to 1.5 per cent.
Before the main publications were available to practitioners, we began to notice that some physicians who participated in the trial seemed to have been unable to follow the study protocol. They did an episiotomy regardless of whether the protocol card told them to or not; in a randomized controlled trial, you would expect an episiotomy would be done approximately half the time. These same participants seemed to be responsible for most of the severe trauma. In contrast, other physicians seemed able to follow the protocol and avoid severe trauma and have the fewest complications. Because of this observation, as a final part of our study, we had all the physicians in the trial answer a questionnaire asking them for their attitudes about a range of birth issues. We learned that those participants who had the worst outcomes in the trial thought the most negatively about birth itself. They had trouble seeing the women or their perineum as normal enough to be randomized—and they seemed to see the birth through fetal-distress-coloured glasses. They saw fetal distress frequently, whereas those physicians with the least trauma in their births saw birth as normal and rarely diagnosed fetal distress.
With the episiotomy studies winding down, my research colleague Janusz Kaczorowski and I began thinking about the role of attitudes and beliefs of all kinds of maternity caregivers and outcomes. Janusz, a sociologist by training, knew nothing about birth at the start. By the end of the study, his knowledge of birth was monumental. Like those who thought the world was flat and the sun revolved around the earth, believers in routine episiotomy considered its use to be based on “normal science.” Obstetricians fully accepted routine episiotomy as normal, even essential. The OB/GYN community saw birth as inherently abnormal; therefore, acceptable scientific questions were grounded in this reality as the only framework for legitimate inquiry.
I found Thomas Kuhn’s The Structure of Scientific Revolutions helpful in my understanding of the conflict between old and new ideas about episiotomy.9 Kuhn defined “revolutionary science” as the study of anomalies, or the failure of the accepted paradigm to explain or take into account observed phenomena. In the 1970s and ’80s, beliefs about childbirth were coming under intense scrutiny. Worldwide, many people had come to believe that routine episiotomy did not make sense and was anomalous and in need of formal study. In the early 1980s, as I struggled to get the episiotomy trial published because the dominant culture wanted the results buried, I thought about how strongly held beliefs came about and the critical importance of timing. I found it helpful to consider my struggle in the context of paradigms and “paradigm shift,” the term coined by Kuhn.
To fully understand the genesis of routine episiotomy, I had been reading the seminal work of Dr. Joseph B. DeLee. I was struck by the way that he put together the need for a new way of protecting the mother and the fetus with the need of his evolving professional discipline. Dr. DeLee was in the process of transforming the field of gynecology into a new discipline to be called obstetrics and gynecology, while wrestling birth away from “incompetent general practitioners and midwives,” and he was inventing routine episiotomy as a vehicle for achieving both.10
Dr. DeLee’s presidential address to what was then the American Gynecological Society in Chicago in 1920 was a masterpiece that proposed a new way to save babies and the perineum and pelvic floor, with his combination of outlet forceps and episiotomy.11 Dr. DeLee exhorted his audience to take up this new approach, claiming that since GPs and midwives would not have the tools nor the inclination to use a surgical technique, the new discipline of OB/GYN would gain hegemony. His timing was impeccable. Mothers and babies were indeed in trouble in the 1920s—especially in the slums of Chicago, where DeLee had founded the Chicago Lying-In Hospital. Society needed a new way of looking at birth, and gynecologists needed a strengthened discipline. To accomplish this, they had to situate themselves as scientifically providing the solution to a problem. Under DeLee’s influence, gynecologists created a new way of viewing birth—changing it from a natural phenomenon to a process fraught with danger, a danger that would be mitigated by the new discipline of obstetrics and gynecology. And society was ready for this way of seeing birth. Thomas Kuhn would say that the old paradigm was about to be shifted.
Having struggled for funding, now I struggled to publish results that contested conventional wisdom. Now the peer reviewers for the journals that I submitted to made misogynistic comments and were harsh in their desire to see the research disappear. I wrote about this fascinating process, using the reviewers’ actual words as the raw material.12 I appreciated that the reviewers were in a different place from our research group. I was not angry at their responses. It was all grist for the mill. What do you expect when you are fighting the current paradigm?
It was unusual for a researcher/author to call a journal editor to complain, but that is what I did. I read to him some of the reviewers’ comments. Editors want their journal to be cutting edge and often controversial. He sent the paper out to a new, carefully selected group of reviewers. The journal then published a series of our episiotomy papers.13 Our results not only showed that episiotomy caused the most severe form of trauma but was more painful than spontaneous tears, interfered with resumption of sexual intercourse and had negative effects on the pelvic floor.14 When the research was finally published, it was because the discipline of OB/GYN had within its leadership a key editor, who was also skeptical of the old orthodoxy and believed that routine episiotomy should be studied.
Janusz and I found that belief structures about episiotomy were firmly grounded in a strongly held paradigm of birth. If you knew how practitioners saw episiotomy, you knew how they viewed birth itself. Our timing was perfect, in line with a rapidly evolving scientific revolution, with obstetrics and gynecology reluctantly becoming evidence-based across a whole range of procedures in common use.
Today, there remain only a few holdouts who still believe that routine episiotomy is beneficial and deny the improvements in perineal and pelvic floor health that accrued from abandonment of routine episiotomy. The new generation of practitioners accepts that routine episiotomy causes the very trauma that it was supposed to prevent. They use it judiciously, which has resulted in a dramatic reduction in its use in North America and a parallel reduction in severe trauma. Those who still cling to the regular use of episiotomy will retire. We can only hope that evidence of the problems with overuse of Caesarean section will follow a similar course, but it is going to be difficult.
It is rare for family doctors to lead the way in obstetrical care or to successfully contest conventional practice, as obstetricians are considered the experts. But since our group led the way on the episiotomy story in our Montreal hospital setting, it was an easy step for us to engage in other ways. As our family practice maternity group expanded, I became aware of the use of soft cup vacuum extraction as a possible replacement, in some clinical situations, for the more invasive and potentially dangerous metal forceps. The disposable single-use device is like a mini toilet plunger, which is placed on the scalp of a fetus and attached to a handheld low intensity suction pump for the purpose of assisting the mother to birth her baby in the final stages of labour. The soft plastic cup is more forgiving than metal forceps, in that it just magnifies the mother’s own efforts at delivering her baby. The use of forceps requires more skill than vacuum, so vacuum is very useful for family doctors, as few family doctors feel comfortable using forceps. As well, it is often unnecessary to do an episiotomy with the device. Typically, the vacuum is applied when the fetal head is low on the pelvic floor, or when the fetal head is almost crowning, but the woman is still unable to complete the birth. In the ideal situation, as the fetal head approaches full crowning, the cup is removed and the birth proceeds without the vacuum—and the mother feels, as she should, that she birthed her baby herself. I always prepared the mother by emphasizing that it was her birth experience, and that we would use the vacuum together.
When I became aware of the benefits of the device, I tried to interest the hospital OB/GYN department in obtaining some of the devices, but they were not interested. Real men use metal. So I bought some of the devices and pumps. The manufacturer supplies the plastic cups and attached handles in sterile plastic bags, some of which I stored in my locker in the maternity suite. When I began to use the vacuums, the nurses were at first skeptical but soon supportive, as they saw that problems were being solved in a less invasive and potentially dangerous way. I began to make myself available to other family doctors to assist if requested. Soon, some of the OB residents were intrigued and asked me to teach them. In a short time, the OB/GYN department purchased the devices and made them available as a part of normal practice.
Compared to the struggle around the limitation of episiotomy to specific indications, this little episode about changing practice seemed unusually easy to implement. Perhaps it was because, in the end, it did not challenge the conventional power structure. Forceps still had a place in obstetrical practice, and vacuum was still a tool that normally would not be used by midwives. Dr. DeLee would probably have approved. While we were making this change locally, in many other hospitals, family doctors and obstetricians were embracing the use of vacuum as a substitute for forceps for some indications. In fact, obstetricians were restricting their own use of forceps, especially high and rotational forceps, preferring Caesarean section as a solution for most complex arrests of labour, which has resulted in the loss of an important skill set and contributed to the rising Caesarean section rate.
