How to promote ‘discipline without tough love’ during pregnancy: a randomized controlled trial

Ethical issues

This study was conducted after receiving approval from the ethics committee of the Japanese Red Cross Katsushika Maternity Hospital (2017-002). This study was carried out in accordance with the Declaration of Helsinki. Written informed consent from each participant was obtained before enrolment. Blinding was performed in the clinicians responsible for one-month postpartum care.

Trial background

The present study was a prospective investigation of all Japanese women with singleton pregnancies who visited our hospital for a perinatal visit at 20–23 weeks’ gestation between November 2017 and March 2018 and delivered a healthy neonate at ≥ 37 weeks’ gestation at our hospital as a result. In this study, we excluded women with perinatal complications such as preterm delivery, low-birth-weight infant, and neonatal asphyxia requiring neonatal admission. This was because individual and important mental health care is needed for mothers whose babies have health problems^9,10. When this study was planned, the required sample size was 762 participants for 90% power based on a previous observation in Japan¹¹; the trial recruited 882 participants. In our institute, midwives carry out three health consultations during pregnancy to support the healthy lives of pregnant women. These consultations are at about 8–11, 20–23, and 34–36 weeks’ gestation. During the study period, at the second health consultation at 20–23 weeks’ gestation, the responsible midwife handed the leaflet directly to the pregnant women randomly selected with the comment of ‘a leaflet concerning the things to keep in mind for healthy childrearing after delivery’. In detail, pregnant women were randomly assigned to the two groups (with and without the leaflet) early in the morning on the day of health consultations using a web-based randomization system (Research Randomizer) stratified by parity (primipara vs. multipara) according to the computer-generated randomization code. We ensured their voluntary participation by allowing them the freedom not to receive leaflets. The midwives handed the leaflet with explanations what was written. That is, they explained about the child discipline to the pregnant women in the intervention group actively from them; however, we explained to the women in the control group only when asked. We conducted the random assignment after obtaining the women’s consent. Unfortunately, however, we did not check whether or not the women in the intervention group actually read the leaflet.

Variables assessed

In this study, we examined the maternal feelings (bonding situation) toward babies of women who received the leaflet in comparison with that in women who did not receive it during the routine health check-up performed one month after delivery using the Japanese version of Mother-to-Infant Bonding Scale (MIBS-J), which is a simple self-administrated questionnaire designed to detect problems with a mother’s feelings towards her newborn baby^12–15. MIBS-J has been demonstrated to be acceptable reliability and reasonable construct validity concerning affection and anger/rejection in Japanese postpartum women¹¹. If a score is higher than 3, there is a possibility that the mother will have problems regarding feelings for her baby. If at least one of the third and fifth questions of MIBS-J (third question: feel resentful toward my baby; fifth question: feel angry toward my baby) is ≥ 1, the possibility of feeling-related problems also existed^11,15.

The items recorded as obstetric and perinatal characteristics that may affect the results were as follows: maternal age, parity, history of abortion, history of infertility treatment, economic problems, results of the modified Violence Against Women Screen (VAWS)^16–18, results of the Whooley questions during the early pregnancy^18,19, presence or absence of participation in a parents class, and delivery modes. As a general rule in our institute, whether or not to participate in the parents' class is decided early in the pregnancy.

The modified VAWS is a Japanese screening instrument for intimate partner violence (IPV) to identify pregnant women who have experienced abuse based on scores using a 3-point Likert scale^13–15. The total score ranges from 0–9; a score higher than 2 is positive for IPV. Whooley questions comprise a screening instrument for depression in the general adult population including pregnant and postpartum women^17,20. If at least one of the two questions is ‘yes’, we diagnose the woman with depressive symptom.

If a pregnant woman was supported by the hospitalization assistance policy (HAP) system of the Japanese Child Welfare Government, we defined her as having economic problems^21,22. The HAP system assists with delivery costs. The main objectives of the HAP system are to help pregnant women who: 1) receive livelihood protection because they are unable to maintain minimum living standards due to poverty, 2) live in households exempt from residence tax, and 3) live in households in which the income tax is less than ¥8,400 (=about $80 US) per year. In this study, the diagnosis of depression was performed by Japanese psychiatric specialists.

The parents’ class in our institute is a participatory group offering guidance in which pregnant women can learn about pregnancy, childbirth, and child rearing together with their partners²³.

In Japan, women without obstetric complications can freely select their birthing facility even at late pregnancy. Our institute is one of the major perinatal centers in Tokyo, Japan (about 2,000 deliveries per year); however, medical care by psychiatrists is not carried out. Therefore, almost all pregnant women complicated by depression receive psychotherapy in nearby psychiatric clinics. Neonatal asphyxia was defined as a neonatal Apgar score at 1 or 5 min of < 7. Postpartum hemorrhage was defined as an estimated blood loss of ≥ 1,000 mL. In most cases, the gestational age was defined based on ultrasonography at 9–11 weeks of gestation. In cases with a delayed first visit, the gestational age was confirmed based on Neonatal Neurological Assessment.

Outcomes

The primary end point of was the effect of the leaflet ‘Discipline Without Tough -Love’ on the score of the MIBS-J in mothers at one month after delivery.

Statistical analysis

Data are expressed as the number (percentage). SPSS Statistics software version 20 (IBM Corp., Armonk, NY, USA) was used for statistical analyses. A chi-square test was used for categorical data, and a p-value < 0.05 was considered significant. Logistic regression analysis was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs).

Study and participant background

Figure 2 shows a flow diagram for the study. During the study period, 882 pregnant women visited our hospital for a perinatal visit and received the midwives’ health consultations at 20–23 weeks’ gestation. Ultimately, a randomized prospective study was conducted involving 334 women who received the consultations with the leaflet of ‘discipline without tough love’ and 320 women who received the standard consultations without the leaflet as a control group.

Figure 2. Flow diagram of the study.

Table 1 shows the characteristics of the two groups of women who examined their maternal feelings at one month after delivery using the MIBS-J as follows: those who received the consultations with the ‘discipline without tough love’ leaflet (n = 334), and those who received the standard consultations without the leaflet (n = 320). As shown in Table 1, there were no significant differences in the clinical characteristics such as maternal age, parity, history of infertility treatment, the rate of having economic problems, the rate of positive of the modified VAWS or the Whooleys’ question, performed at the first trimester of pregnancy between the two groups. Table 2 shows the delivery modes of the two groups. There were no significant differences in the delivery modes between the two groups. These indicate that the randomization of this study was performed equally effectively as a result. Individual-level results are available as Underlying data²⁴.

Outcomes

Table 3 shows the results of maternal feelings for their babies at one month after delivery using the MIBS-J in the two groups as follows: those who received the consultations with the leaflet of ‘discipline without tough love’, and those who received the standard consultations without the leaflet. As shown in Table 3, there were no significant differences in the rate of score ≥ 3, or yes for the third or the fifth question of the MIBS-J indicating problems with maternal feelings between the two groups.

The prevalence of women showing problems with maternal feelings in the control group was 15%. It is estimated that a definitive trial powered to detect the same difference in prevalence would require approximately 556 patients equally divided into the current two groups (two-tailed α = 0.05, β = 0.2), Therefore, the sample size of the current observation would be sufficient. There indicate that the awareness of ‘discipline without tough love’ through the leaflet during pregnancy was not very effective for the maternal feelings at one month after delivery.