Objective
The objective of the study was to evaluate the impact of doula support on first-trimester abortion care.
Study Design
Women were randomized to receive doula support or routine care during first-trimester surgical abortion. We examined the effect of doula support on pain during abortion using a 100 mm visual analog scale. The study had the statistical power to detect a 20% difference in mean pain scores. Secondary measures included satisfaction, procedure duration, and patient recommendations regarding doula support.
Results
Two hundred fourteen women completed the study: 106 received doula support, and 108 received routine care. The groups did not differ regarding demographics, gestational age, or medical history. Pain scores in the doula and control groups did not differ at speculum insertion (38.6 [±26.3 mm] vs 43.6 mm [±25.9 mm], P = .18) or procedure completion (68.2 [±28.0 mm] vs 70.6 mm [±23.5 mm], P = .52). Procedure duration (3.39 [±2.83 min] vs 3.18 min [±2.36 min], P = .55) and patient satisfaction (75.2 [±28.6 mm] vs 74.6 mm [±27.4 mm], P = .89) did not differ between the doula and control groups. Among women who received doula support, 96.2% recommended routine doula support for abortion and 60.4% indicated interest in training as doulas. Among women who did not receive doula support, 71.6% of women would have wanted it. Additional clinical staff was needed to provide support for 2.9% of women in the doula group and 14.7% of controls ( P < .01).
Conclusion
Although doula support did not have a measurable effect on pain or satisfaction, women overwhelmingly recommended it for routine care. Women receiving doula support were less likely to require additional clinic support resources. Doula support therefore may address patient psychosocial needs.
Full-spectrum doulas are lay people who provide support to women across a variety of reproductive experiences, including birth, miscarriage, adoption, and abortion. Doula support during labor and delivery is associated with improved pain control, shorter labor, decreased rates of cesarean delivery, and increased breast-feeding.
In abortion care, doulas may serve as an important source of emotional and social support. Additionally, many women who undergo abortion are unlikely to have adequate pain control. In a survey of National Abortion Federation member sites, 46% of clinics provide local anesthesia with or without oral premedication, 33% local anesthesia with intravenous sedation, and 21% deep sedation or general anesthesia for first-trimester abortions. A 2010 literature review concluded that many patients who do not receive general anesthesia find first-trimester surgical abortion uncomfortable.
During abortion procedures, doulas adopt techniques and skills used in birth settings that may aid in pain management. Although, to date, no studies have assessed doulas at the time of abortion, 1 study evaluating support people in an abortion clinic recovery room reported overwhelmingly positive experiences. We conducted a nonblinded, randomized controlled trial to assess the effect of doula support on pain during first-trimester abortion. We hypothesized that women randomized to doula support would have statistically significant less pain compared with women randomized to usual care.
Materials and Methods
Women seeking a first-trimester surgical abortion at the John H. Stroger Jr Hospital of Cook County were recruited between May 2013 and July 2013. The institutional review boards of both the John H. Stroger Jr Hospital of Cook County and The University of Chicago (both in Chicago, IL) approved the study protocol and procedures.
Prior to the start of the study, a family-planning, fellowship-trained obstetrician gynecologist and 2 doulas with 5 years of combined experience providing labor and delivery and abortion support (doula trainers) designed and conducted a 2 day doula training. The curriculum consisted of 6 lectures, group discussions, and role playing, including the following topics: medical and psychosocial aspects of abortion care, pregnancy options counseling, clinic logistics, and team building. Trainees learned and practiced doula techniques such as verbal support, handholding, massage, breathing guidance, and relaxation techniques. After completing the training session and prior to functioning independently as a doula in the clinic, trainees shadowed, and were subsequently proctored by, 1 of the 2 doula trainers.
Researchers recruited women for study participation after obtaining ultrasound confirmation of pregnancy, routine clinic preprocedure counseling, and completion of the consent process for first-trimester surgical abortion. Inclusion criteria included gestational age less than 14 0/7 weeks, aged 18 years or older, English speaking, and able to read and understand the study consent forms. Researchers excluded women who declined participation or who did not meet inclusion criteria.
Women were randomized to doula support or usual care. A research team member not involved in participant recruitment or enrollment generated the allocation scheme using a computer-generated random number sequence. An allocation ratio of 1 to 1 was used in block sizes of 10 for group assignment. Researchers ensured concealment by placing group assignments in sequentially numbered, opaque sealed envelopes. We revealed allocation to participants at the time of the procedure.
Six attending physicians performed abortion procedures according to clinic protocol. Clinic protocol includes receiving 400 μg of buccal misoprostol and 800 mg of ibuprofen before the procedure. Procedures are routinely performed using paracervical block, although administration of local anesthesia is at the discretion of the provider. Physicians perform procedures under ultrasound guidance. Standard protocol includes having at least 1 physician, 1 surgical technician, and an ultrasound technician in the room during the procedure.
Should a patient need additional support for pain or anxiety during the procedure, an additional clinic staff member is asked to come to the room to assist. Per clinic protocol, the patient’s friends, family members, and/or partners are not allowed in the procedure room and remain in the waiting area.
Three doulas provided support during the study period: 1 experienced doula and 2 women who completed abortion doula training and subsequent proctoring. Doulas introduced themselves to the participants upon entry into the procedure room and explained their role at that time. Doulas briefly described the techniques that they commonly used and encouraged women to communicate their preferences regarding which techniques to use. Doulas were present prior to the start of the procedure and through the completion of the procedure and assisted women in returning to the recovery area.
Research assessment points occurred before, during, and after the procedure. After providing informed consent, women were asked to complete a brief demographic survey and a 100 mm visual analog scale (VAS) on baseline anxiety about the procedure (anchors: 0 mm, no anxiety; 100 mm, extremely anxious) and anticipated procedure pain (anchors: 0 mm, no pain; 100 mm, worst pain imaginable). Pain was assessed using a 100 mm VAS (anchors: 0 mm, no pain; 100 mm, worst pain imaginable) at the time of speculum insertion, upon completion of the procedure, and in the recovery room approximately 9 minutes (median, 8.0 min) after the procedure. Following the procedure, all participants rated their satisfaction in response to the question, “How satisfied were you with your experience?” using a 100 mm VAS (anchors: 0 mm, completely unsatisfied; 100 mm, completely satisfied).
Women who received doula support completed additional yes/no questions: “Would you recommend that support people be routinely used during abortion procedures?” and “Would you be interested in training to become an abortion support person?” Women who did not receive doula support were asked, “Do you wish that you had had someone to provide support during your abortion procedure?” In addition, we documented procedure time from speculum insertion to removal as well as procedure difficulty as rated by the provider using a 4-point Likert scale (anchors: “not difficult” and “very difficult”). Providers additionally documented whether a trainee was involved in the procedure, whether participants required additional pain medication, whether participants required additional support from other clinic staff, and whether an adverse event occurred.
We based sample size on the primary outcome of pain at the completion of aspiration. Based on previous studies, we assumed that the mean pain score at the completion of aspiration would be 55 mm. We determined our sample size based on our consideration that a 20% difference in mean pain scores would be clinically relevant. To obtain 80% power with an alpha of 0.05 using a 2-tailed hypothesis, 95 participants were needed in each arm. A total of 220 participants, 110 in each arm, were enrolled to allow for study attrition and incomplete data (pre/postprocedure questions).
We entered all baseline and pre- and postprocedure questionnaire items into an IBM SPSS (version 21.0; IBM, Armonk, NY) for analyses. We conducted analyses according to an intention-to-treat design and used descriptive statistics to describe the characteristics of the 2 groups. To compare the study groups with respect to baseline characteristics and outcomes, we used independent group Student t tests and Wilcoxon signed-rank tests for continuous variables and χ 2 and Fisher exact tests for categorical variables. We considered values of P < .05 to be statistically significant.
Results
A total of 272 women were approached for enrollment in the study; 33 declined to participate and 19 did not meet eligibility criteria (17 because of age requirements and 2 because of language requirements). We enrolled 220 in the study, including 6 women who did not ultimately undergo an abortion procedure, with a total of 214 completing study procedures; 106 were randomized to the doula group and 108 were randomized to the control group (ie, women who did not receive doula support) ( Figure ). The mean age of participants was 24.5 years, with the majority of women (87.7%) identifying as African-American ( Table 1 ). The mean gestational age was 62.5 days and women had an average of 3.6 previous pregnancies, with an average of 1.6 living children, 0.99 previous elective abortions, and 0.22 previous miscarriages. Groups did not differ significantly on demographic and baseline obstetric and gynecological variables ( Table 1 ).
| Characteristic | Doula group (n = 106) | Control group (n = 108) | Significance ( P value) |
|---|---|---|---|
| Age, y | 24.8 ± 4.96 | 24.3 ± 4.99 | .48 |
| Race/ethnicity | 84.9% African American | 90.8% African American | .18 |
| Marital status | 86.8% single | 90.8% single | .69 |
| BMI, kg/m 2 | 29.3 | 28.5 | .44 |
| Gestational age, d | 62.4 ± 15.5 | 62.5 ± 15.3 | .96 |
| Gravidity | 3.5 ± 1.8 | 3.6 ± 2.2 | .89 |
| Previous vaginal deliveries | 1.3 ± 1.2 | 1.3 ± 1.3 | .79 |
| Previous elective abortions | 0.94 ± 1.0 | 1.0 ± 1.8 | .77 |
| Previous dilation and curettage | 1.9% | 4.6% | .27 |
| Previous LEEP | 3.8% | 3.7% | .97 |
| Previous cervical conization | 0.9% | 0.9% | .98 |
| Previous cervical laser ablation | 0.9% | 0% | .31 |
Measures of pain and anxiety did not differ between the 2 groups at any of the assessment points. At baseline, there were no significant differences in VAS scores on anticipated pain (mean, 51.9 mm compared with 55.0 mm; P = .43) and anxiety (mean, 60.3 mm compared with 54.9 mm; P = .23) ( Table 2 ). Additionally, the doula and control groups did not differ with regard to pain at the time of speculum insertion (mean, 38.6 mm compared with 43.6 mm; P = .18) or pain with the abortion procedure (mean, 68.2 mm compared with 70.6 mm; P = .52). No differences were found for procedure duration between women randomized to doula care and those randomized to routine care (mean, 3.4 minutes, median, 3.0 minutes compared with 3.2 minutes, median, 3.0 minutes; P = .55).
