ACOG PublicationACOG Practice Bulletin Number 49, December 2003: Dystocia and Augmentation of Labor
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The OdonAssist inflatable device for assisted vaginal birth—the ASSIST II study (United Kingdom)
2024, American Journal of Obstetrics and GynecologyDecreasing rates of assisted vaginal birth have been paralleled with increasing rates of cesarean deliveries over the last 40 years. The OdonAssist is a novel device for assisted vaginal birth. Iterative changes to clinical parameters, device design, and technique have been made to improve device efficacy and usability.
This study aimed to determine if the feasibility, safety, and efficacy of the OdonAssist device were sufficient to justify conducting a future randomized controlled trial.
An open-label nonrandomized study of 104 participants having a clinically indicated assisted vaginal birth using the OdonAssist was undertaken at Southmead Hospital, Bristol, United Kingdom. Data were also collected from participants who consented to participate in the study but for whom trained OdonAssist operators were not available, providing a nested cohort. The primary clinical outcome was the proportion of births successfully expedited with the OdonAssist. Secondary outcomes included clinical, patient-reported, operator-reported, device and health care utilization. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90. Given that the number of successful OdonAssist births was ≥61 out of 104, the hypothesis of a poor rate of 50% was rejected in favor of a good rate of ≥65%.
Between August 2019 and June 2021, 941 (64%) of the 1471 approached, eligible participants consented to participate. Of these, 104 received the OdonAssist intervention. Birth was assisted in all cephalic vertex fetal positions, at all stations ≥1 cm below the ischial spines (with or without regional analgesia). The OdonAssist was effective in 69 of the 104 (66%) cases, consistent with the hypothesis of a good efficacy rate. There were no serious device-related maternal or neonatal adverse reactions, and there were no serious adverse device effects. Only 4% of neonatal soft tissue bruising in the successful OdonAssist group was considered device-related, as opposed to 20% and 23% in the unsuccessful OdonAssist group and the nested cohort, respectively. Participants reported high birth perception scores. All practitioners found the device use to be straightforward.
Recruitment to an interventional study of a new device for assisted vaginal birth is feasible; 64% of eligible participants were willing to participate. The success rate of the OdonAssist was comparable to that of the Kiwi OmniCup when introduced in the same unit in 2002, meeting the threshold for a randomized controlled trial to compare the OdonAssist with current standard practice. There were no disadvantages of study participation in terms of maternal and neonatal outcomes. There were potential advantages of using the OdonAssist, particularly reduced neonatal soft tissue injury. The same application technique is used for all fetal positions, with all operators deeming the device straightforward to use. This study provides important data to inform future study design.
Impact of discontinuing oxytocin in active labour on neonatal morbidity: an open-label, multicentre, randomised trial
2023, The LancetOxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity.
STOPOXY was a multicentre, randomised, open-label, controlled, superiority trial conducted in 21 maternity units in France. Participants who received oxytocin before 4 cm dilation were randomly assigned 1:1 to either discontinuous oxytocin (oxytocin infusion stopped beyond a cervical dilation equal to or greater than 6 cm) or continuous oxytocin (administration of oxytocin continued until delivery). Randomisation was stratified by centre and parity. The primary outcome, neonatal morbidity, was assessed at birth using a composite variable defined by an umbilical arterial pH at birth less than 7·10, a base excess greater than 10 mmol/L, umbilical arterial lactates greater than 7 mmol/L, a 5-min Apgar score less than 7, or admission to the neonatal intensive care unit. Efficacy and safety was assessed in participants who were randomly assigned (excluding those who withdrew consent or were deemed ineligible after randomisation) and had reached a cervical dilation of at least 6 cm. This trial is registered with ClinicalTrials.gov, NCT03991091.
Of 2459 participants randomly assigned between Jan 13, 2020, and Jan 24, 2022, 2170 were eligible to receive the intervention and were included in the final modified intention-to-treat analysis. The primary outcome occurred for 102 (9·6%) of 1067 participants (95% CI 7·9 to 11·5) in the discontinuous oxytocin group and for 101 (9·2%) of 1103 participants (7·6 to 11·0) in the continuous oxytocin group; absolute difference 0·4% (95% CI –2·1 to 2·9); relative risk 1·0 (95% CI 0·8 to 1·4). There were no clinically significant differences in adverse events between the two groups of the safety population.
Among participants receiving oxytocin in early labour, discontinuing oxytocin when the active phase is reached does not clinically or statistically significantly reduce neonatal morbidity compared with continuous oxytocin.
French Ministry of Health and the Département de la Recherche Clinique et du Développement de l'Assistance Publique–Hôpitaux de Paris.
Maternal factors associated with labor dystocia in low-risk nulliparous women. A systematic review and meta-analysis
2023, Sexual and Reproductive HealthcareTo identify maternal factors associated with labor dystocia in low-risk nulliparous women.
MEDLINE, Embase, ClinicalTrials.gov, Cochrane, and CINAHL were searched for intervention studies and observational studies published from January 2000 to January 2022. Low-risk was defined as nulliparous women with a singleton, cephalic birth in spontaneous labor at term. Labor dystocia was defined by national or international criteria or treatment. Countries were restricted to OECD members. Two authors independently screened 11,374 titles and abstracts, extracted data, and assessed risk of bias using the Newcastle-Ottawa Scale. Results were presented narratively and by meta-analysis when compatible.
Seven cohort studies were included. Overall, the certainty of the evidence was moderate. Three studies found that higher maternal age was associated with an increased frequency of labor dystocia (relative risk 1.68; 95% CI 1.43–1.98). Further three studies found that higher maternal BMI was associated with increased frequency of labor dystocia (relative risk 1.20; 95% CI 1.01–1.43). Maternal short stature, fear of childbirth, and high caffeine intake were also associated with an increased frequency of labor dystocia, while maternal physical activity was associated with a decreased frequency.
Maternal factors associated with an increased frequency of labor dystocia were mainly maternal age, physical characteristics, and fear of childbirth. Maternal physical activity was associated with a decreased frequency. Intervention studies targeting these maternal factors would need to be initiated before or early in pregnancy to test the causality of the identified factors and labor dystocia.
Assessment of uterine contractions in labor and delivery
2023, American Journal of Obstetrics and GynecologyNormal labor and delivery are dependent on the presence of regular and effective contractions of the uterine myometrium. The mechanisms responsible for the initiation and maintenance of adequate and synchronized uterine activity that are necessary for labor and delivery result from a complex interplay of hormonal, mechanical, and electrical factors that have not yet been fully elucidated.
Monitoring uterine activity during term labor and in suspected preterm labor is an important component of obstetrical care because cases of inadequate and excessive uterine activity can be associated with substantial maternal and neonatal morbidity and mortality. Inadequate labor progress is a common challenge encountered in intrapartum care, with labor dystocia being the most common indication for cesarean deliveries performed during labor. Hereafter, an accurate assessment of uterine activity during labor can assist in the management of protracted labor by diagnosing inadequate uterine activity and facilitating the titration of uterotonic medications before a trial of labor is prematurely terminated. Conversely, the ability to diagnose unwanted or excessive uterine activity is also critical in cases of threatened preterm labor, tachysystole, or patients undergoing a trial of labor after cesarean delivery. Knowledge of uterine activity in these cases may guide the use of tocolytic medications or raise suspicion of uterine rupture. Current diagnostic capabilities are less than optimal, hindering the medical management of term and preterm labor.
Currently, different methods exist for evaluating uterine activity during labor, including manual palpation, external tocodynamometry, intrauterine pressure monitoring, and electrical uterine myometrial activity tracing. Legacy uterine monitoring techniques have advantages and limitations. External tocodynamometry is the most widespread tool in clinical use owing to its noninvasive nature and its ability to time contractions against the fetal heart rate monitor. However, it does not provide information regarding the strength of uterine contractions and is limited by signal loss with maternal movements. Conversely, the intrauterine pressure catheter quantifies the strength of uterine contractions; however, its use is limited by its invasiveness, risk for complications, and limited additive value in all but few clinical scenarios. New monitoring methods are being used, such as electrical uterine monitoring, which is noninvasive and does not require ruptured membranes. Electrical uterine monitoring has yet to be incorporated into common clinical practice because of lack of access to this technology, its high cost, and the need for appropriate training of clinical staff. Further work needs to be done to increase the accessibility and implementation of this technique by experts, and further research is needed to implement new practical and useful methods. This review describes current clinical tools for uterine activity assessment during labor and discusses their advantages and shortcomings.
The review also summarizes current knowledge regarding novel technologies for monitoring uterine contractions that are not yet in widespread use, but are promising and could help improve our understanding of the physiology of labor, delivery, and preterm labor, and ultimately enhance patient care.
The latent phase of labor
2023, American Journal of Obstetrics and GynecologyThe latent phase of labor extends from the initiation of labor to the onset of the active phase. Because neither margin is always precisely identifiable, the duration of the latent phase often can only be estimated. During this phase, the cervix undergoes a process of rapid remodeling, which may have begun gradually weeks before. As a consequence of extensive changes in its collagen and ground substance, the cervix softens, becomes thinner and dramatically more compliant, and may dilate modestly. All of these changes prepare the cervix for the more rapid dilatation that will occur during the active phase to follow. For the clinician, it is important to recognize that the latent phase may normally extend for many hours. The normal limit for the duration of the latent phase should be considered to be approximately 20 hours in a nullipara and 14 hours in a multipara. Factors that have been associated with a prolonged latent phase include deficient prelabor or intrapartum cervical remodeling, excessive maternal analgesia or anesthesia, maternal obesity, and chorioamnionitis. Approximately 10% of women with a prolonged latent phase are actually in false labor, and their contractions eventually abate spontaneously. The management of a prolonged latent phase involves either augmenting uterine activity with oxytocin or providing a sedative-induced period of maternal rest. Both are equally effective in advancing the labor to active phase dilatation. A very long latent phase may be a harbinger of other labor dysfunctions.
Obstetric Analgesia and Anesthesia
2023, Avery's Diseases of the NewbornLabor results in significant pain for many women that is individualized, dynamic, and unpredictable. Although the effects of obstetric analgesia and anesthesia on the fetus and neonate are typically benign, there is potential for adverse neonatal effects. During pregnancy and labor women undergo fundamental changes in anatomy and physiology that affect all organ systems, significantly alter pharmacokinetic and pharmacodynamics responses to many drugs commonly used in anesthesia, and have important implications for anesthetic administration. Opioids are commonly used for labor analgesia, but are administered with limitations on both dose and timing because they readily cross the placenta and are associated with a risk of neonatal respiratory depression in a dose-dependent fashion. Inhaled nitrous oxide can provide limited labor analgesia and is safe for the neonate. Neuraxial analgesia (epidural or spinal) is widely used and the most effective method for labor analgesia. Epidural labor analgesia is a catheter-based technique that provides continuous analgesia during labor with administration of medication into the epidural space. Neuraxial analgesia does not affect the length of the first stage of labor or increase the risk for cesarean delivery, and with use of more current techniques is no longer associated with an increased use of instrumented vaginal delivery (forceps or vacuum). For the patient without an epidural catheter, spinal anesthesia is the most common anesthetic technique used for cesarean delivery. Use of general anesthesia for cesarean delivery is typically reserved for situations where neuraxial anesthesia is contraindicated or emergent delivery is needed.