Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.
OBJECTIVE: To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management. METHODS: We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested. RESULTS: Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05). CONCLUSION: Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
El-Sayed YY; Rice MM; Grobman William A; Reddy UM; Tita ATN; Silver RM; Mallett Gail; Hill Kim; Thom EA; Wapner RJ; Rouse DJ; Saade GR; Thorp JM; Chauhan SP; Chien EK; Casey BM; Gibbs RS; Srinivas SK; Swamy GK; Simhan HN; Macones GA
Obstetrics and Gynecology
2020
2020-10
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1097/aog.0000000000004055" target="_blank" rel="noreferrer noopener">10.1097/aog.0000000000004055</a>
Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage.
OBJECTIVE: To evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment. METHODS: ptA multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device. RESULTS: Of 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%). CONCLUSION: Intrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality. FUNDING SOURCE: Alydia Health, Inc. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02883673.
D'Alton ME; Rood KM; Smid MC; Simhan HN; Skupski DW; Subramaniam A; Gibson KS; Rosen T; Clark SM; Dudley D; Iqbal SN; Paglia MJ; Duzyj CM; Chien EK; Gibbins KJ; Wine KD; Bentum NA; Kominiarek MA; Tuuli MG; Goffman D
Obstetrics and Gynecology
2020
2020-09-09
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1097/aog.0000000000004138" target="_blank" rel="noreferrer noopener">10.1097/aog.0000000000004138</a>
Maternal Sense of Control During Childbirth and Infant Feeding Method.
Humans; Pregnancy; Adult; Female; Young Adult; Personal Autonomy; Breast Feeding/psychology; Delivery Obstetric/psychology
OBJECTIVE: To estimate whether maternal sense of control in labor is associated with breastfeeding at 4-8 weeks postpartum. METHODS: This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6-96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4-8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders. RESULTS: Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4-8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182). The median Labor Agentry Scale score was 169 (interquartile range 151-183) for women exclusively breastfeeding, 166 (interquartile range 142-182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142-181) for women who were only formula feeding (P<.001). In the unadjusted multinomial model, women with Labor Agentry Scale scores in the lowest two quintiles (ie, those with lower perceived control during childbirth) were less likely to be exclusively breastfeeding (as compared with those exclusively formula feeding) than women in the highest Labor Agentry Scale quintile. When controlling for confounders, however, this association was no longer significant. CONCLUSION: After adjustment for confounders, perceived control during childbirth was not associated with breastfeeding at 4-8 weeks postpartum among nulliparous women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT01990612.
Dude A; Fette LM; Reddy UM; Tita ATN; Silver RM; El-Sayed YY; Wapner RJ; Rouse DJ; Saade GR; Thorp JM; Chauhan SP; Iams JD; Chien EK; Casey BM; Srinivas SK; Swamy GK; Simhan HN
Obstetrics and Gynecology
2020
2020-03
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
journalArticle
<a href="http://doi.org/10.1097/aog.0000000000003697" target="_blank" rel="noreferrer noopener">10.1097/aog.0000000000003697</a>