Randomized Trial of Labor Induction in Women 35 Years of Age or Older.

BACKGROUND: The risk of antepartum stillbirth at term is higher among women 35 years of age or older than among younger women. Labor induction may reduce the risk of stillbirth, but it also may increase the risk of cesarean delivery, which already is common in this older age group. METHODS: We conducted a randomized, controlled trial involving primigravid women who were 35 years of age or older. Women were randomly assigned to labor induction between 39 weeks 0 days and 39 weeks 6 days of gestation or to expectant management (i.e., waiting until the spontaneous onset of labor or until the development of a medical problem that mandated induction). The primary outcome was cesarean delivery. The trial was not designed or powered to assess the effects of labor induction on stillbirth. RESULTS: A total of 619 women underwent randomization. In an intention-to-treat analysis, there were no significant between-group differences in the percentage of women who underwent a cesarean section (98 of 304 women in the induction group [32%] and 103 of 314 women in the expectant-management group [33%]; relative risk, 0.99; 95% confidence interval [CI], 0.87 to 1.14) or in the percentage of women who had a vaginal delivery with the use of forceps or vacuum (115 of 304 women [38%] and 104 of 314 women [33%], respectively; relative risk, 1.30; 95% CI, 0.96 to 1.77). There were no maternal or infant deaths and no significant between-group differences in the women's experience of childbirth or in the frequency of adverse maternal or neonatal outcomes. CONCLUSIONS: Among women of advanced maternal age, induction of labor at 39 weeks of gestation, as compared with expectant management, had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes. (Funded by the Research for Patient Benefit Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN11517275.).

Induction of labour versus expectant management for nulliparous women over 35 years of age: a multi-centre prospective, randomised controlled trial.

BACKGROUND: British women are increasingly delaying childbirth. The proportion giving birth over the age of 35 rose from 12% in 1996 to 20% in 2006. Women over this age are at a higher risk of perinatal death, and antepartum stillbirth accounts for 61% of all such deaths. Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks.Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk. In a national survey of obstetricians 37% already induce women aged 40-44 years. A substantial minority of parents support such a policy, but others do not on the grounds that it might increase the risk of Caesarean section. However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections, rather the reverse. If induction for women over 35 did not increase Caesareans, or even reduced them, it would plausibly improve perinatal outcome and be an acceptable intervention. We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates.This trial is funded by the NHS Research for Patient Benefit (RfPB) Programme. DESIGN: The 35/39 trial is a multi-centre, prospective, randomised controlled trial. It is being run in twenty UK centres and we aim to recruit 630 nulliparous women (315 per group) aged over 35 years of age, over two years. Women will be randomly allocated to one of two groups: Induction of labour between 39°/7 and 396/7 weeks gestation. Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessitating either induction of labour or Caesarean Section.The primary purpose of this trial is to establish what effect a policy of induction of labour at 39 weeks for nulliparous women of advanced maternal age has on the rate of Caesarean section deliveries. The secondary aim is to act as a pilot study for a trial to answer the question, does induction of labour in this group of women improve perinatal outcomes? Randomisation will occur at 36°/7-396/7 weeks gestation via a computerised randomisation programme at the Clinical Trials Unit, University of Nottingham. There will be no blinding to treatment allocation. DISCUSSION: The 35/39 trial is powered to detect an effect of induction of labour on the risk of caesarean section, it is underpowered to determine whether it improves perinatal outcome. The current study will also act as a pilot for a larger study to address this question. TRIAL REGISTRATION: ISRCTN11517275.

Induction of labour at term for women over 35 years old: a survey of the views of women and obstetricians.

OBJECTIVES: To determine the views of UK women and obstetricians relating to induction of labour at term for women over 35 years of age. STUDY DESIGN: Cross-sectional web-based survey sent to members of the British Maternal and Fetal Medicine Society (BMFMS) and pregnant or recently delivered members of a large social network site for parents (www.mumsnet.com). One hundred and twenty-eight consultant obstetrician members of BMFMS and 663 pregnant or recently delivered women responded. RESULTS: Two hundred and eighty-eight women (43%) would consider induction of labour for maternal age alone, and 192 women (29%) would consider participating in a randomised trial of induction of labour at term versus expectant management in a future pregnancy. Three percent (n=4) of consultant obstetricians offer induction of labour at term to women at 35-39 years of age, 37% (n=47) to women at 40-44 years of age and 55% (n=70) to those over 45 years. Sixty-one consultants (48%) would participate in a trial to test the effect of a policy of induction for nulliparous women over 35 years old. CONCLUSIONS: The policy of offering induction of labour at term for advanced maternal age is widespread and a significant percentage of women consider it to be a valid indication.