Active Management of Labor Versus Expectant Management of Primiparous Women With a Prolonged Latent Phase: A Randomized Trial

doi:10.21203/rs.3.rs-3898562/v1

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Active Management of Labor Versus Expectant Management of Primiparous Women With a Prolonged Latent Phase: A Randomized Trial

https://doi.org/10.21203/rs.3.rs-3898562/v1

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Introduction:

The duration of the latent phase of labour is variable and can reach 20 hours. According to the World Health Organization (WHO), a prolonged latent phase is the absence of cervical dilation beyond four centimeters after eight hours of regular uterine contractions. In this situation, women are at higher risk of medical interventions with a higher rate of emergency caesarean sections. There is no consensus regarding the management of prolonged latent phase. Thus, two attitudes are possible: Expectant management with spontaneous labour and active management with amniotomy and oxytocin infusion.

The aim of our study was to compare the outcomes of expectant management to those of active management strategy in case of prolonged latent phase.

Patients and methods:

We undertook a prospective experimental randomized clinical trial, in the gynecology and obstetrics department of the university hospital Hédi Chaker, Sfax, Tunisia, between July 1st 2021 and December 31 2021. We included in our study primiparous women with spontaneous labor beginning and with prolonged latent phase. Only single evolutive pregnancy with cephalic presentation were included. Patients were randomized into two groups. For Active Management Group (AMG), the intervention was amniotomy followed by an oxytocin influsion. For the expectant management group (EMG), amniotomy and oxytocin infusion were not performed unless indicated. The primary outcome was the rate of cesarean sections.

Results:

Our study population consisted of 340 primiparous parturients with spontaneous labor beginning and with a prolonged latent phase. The caesarean section rate was 27.6% for the EMG versus 43.5% for the AMG (p < 0.001). Immediate complications were found in 18.2% of patients for the AMG versus 2.9% for the EMG (p < 0.001). The most common complication was postpartum hemorrhage (PPH) and was more frequent for AMG (12.4%). At birth, 93.5% of newborns for the EMG had an Apgar score between 8 and 10 versus 84.7% for the AMG (p = 0.01). Medical reanimation was required for 25 newborns after AMG and for 10 cases with EMG (p = 0.01). Five newborns for EMG (2.9%) and 15 newborns for GPA (8.8%) were admitted to the neonatal intensive care unit (p = 0.03).The average time between operation and vaginal delivery was longer for the EMG (15 hours and 47min versus 8 hours, p = 0.001). The mean duration of the latency phase in our study was 20 hours 38min for the EMG versus 13h and 19min for the AMG (p < 0.001). The average duration of the active phase was 5 hours 14min for the EMG versus 3 hours and 58min for the AMG (p < 0.001). Concerning the satisfaction of the parturients, 68.2% for the AMG were satisfied with the delivery process versus 82.4% for the EMG; p = 0.003. For immediate postpartum satisfaction, the majority of patients were very satisfied with no significant difference.

Conclusion:

The active attitude compared to the expectant attitude has shown several disadvantages: it gives more caesarean section rate, more maternal complications, less safety for the newborn, a longer hospital stay with less satisfied parturients. At the end of this study, and in the light of the results found in the literature, expectant management to manage the prolonged latency phase seems to be an effective alternative and we suggest its generalization.

Cesarean

Vaginal delivery

Latent phase of labor

Expectant management

Term

Nullipara

Patient satisfaction.

Labor is a process defined by the association of painful, close and regular uterine contractions. The first stage of labor begins with the first uterine contractions and ends with complete cervical dilation to 10 centimeters. This stage is divided into two phases: the latent phase and the active phase.

The duration of the latent phase of labour is variable and can reach 20 hours (1). According to the World Health Organization (WHO), a prolonged latency phase is the absence of cervical dilation beyond four centimeters after eight hours of regular uterine contraction (2–4). In this situation, parturient women are more likely to be exposed to medical interventions with a higher rate of emergency caesarean sections. There is no consensus regarding the management of these patients (5).

Thus, face to this situation, two attitudes are possible: expectant management consisting in letting labor take place spontaneously, and active management with amniotomy and infusion of oxytocin.

The indications and the reported outcomes of these two management strategies by the different teams are different (5). Thus, the aim of our study was to compare the outcomes of active and expectant management in case of prolonged latent phase.

a) Study design

We undertook a randomized comparative prospective study in the gynecology and obstetrics department of the Hedi Chaker university hospital in Sfax, Tunisia, in a six months period between July 1st, 2021 and December 31, 2021.

The study was registred in the panafrican clinical trial in 07/08/2023 under the number PACTR202308714803965.

b) Study population with selection criteria:

We included in our study:

Primiparous women
Women with a singleton evolutive pregnancy with cephalic presentation.
Women with spontaneous beginning of labor

c) Data collection:

All parturients were examined at admission. After obtaining the informed consent, an individual investigation sheet was drawn up.

Before starting this randomized prospective study, we obtained the agreement of the ethics committee. To determine the number of subjects needed for the study, we developed a preliminary survey to estimate the number of caesarean sections among primiparous women in our population. With an estimated rate of caesarean sections in primiparous women of 34%, the number of required parturients was 170 patients per group, with a power of 80%, a risk of alpha error of 5%, ∆ = 14% and an increase of 10%.

All data were analyzed using Statistical Package for the Social Sciences (SPSS) software, version 2022.

d) Management strategies

Parturients were divided into two groups:

-The Active management Group (AMG): The intervention consisted in amniotomy followed by an infusion of oxytocin.

The initial dose administered was 4 mIU per minute, with dose increasing of 2 mIU every 20 minutes (without exceeding 30 mIU/min). The objective was reaching a uterine contraction rythm of 3 to 5 uterine contractions per 10 minutes.

The expectant management group (EMG)

. We defined the failure of the expectant management as the absence of more than 3 cm cervical dilation after 24 hours of regular uterine contractions. An active management (amniotomy and/or oxytocin infusion) could be required in case of stagnation cervical of dilation for more than 2 hours or an abnormal foetal heart rate.

e) Outcomes

- The primary outcome was the caesarean section rate.

The secondary outcomes of management were:

*Maternal complications

* Neonatal outcomes

* Duration of labor

* Satisfaction of patients

In our study, a total of 340 women were randomized into two groups. The AMG included 170 patients and the EMG was composed of 170 women (Figure 1).

In the EMG, 31 parturients underwent amnitomy for pathological foetal heart rate or stagnant dilation and no patient had oxytocin infusion. These patients were maintained in the same group for the intention-to-treat analysis.

The average age of parturients was 26 years. BMI of 27.33 Kg/m2. All pregnancies were well monitored. According to the baseline characteristics of the parturients, both groups were comparable as well as concerning the newborn characteristics (the aspect of the amniotic fluid, birth weight). Table 1

Table 1

Comparability of groups.
	EMG	AMG	P
Age (average in years)	26.11	26.87	0.13
BMI (in Kg/m2)	26.98	27.68	0.41
Pregnancy monitoring (> 5 CPN)	83.5%	86.5%	0.44
bishop score at 8	69.4%	68.2%	0.67
Appearance of amniotic fluid (clear)	85.3%	75.9%	0.08
Weight of newborn at birth	3188.24	3273.53	0.38
Funicular anomalies	15.88%	12.94%	0.7

The rate of caesarean section was 35.6% in the total study population. The AMG was associated with a more important caesarean section rate than the EMG with a statistically significant difference (respectively 43.5% versus 27.6%, p < 0.001). The main indication for caesarean section was acute fetal distress, which was more frequently reported in the AMG with a significant difference (p = 0.028). The total instrumental delivery rate was 7.4%. This rate was significantly higher in the active management group (P < 0.001). The main indication for instrumental delibery was acute fetal distress with no significant difference between both management groups. Table 2, 3

Table 2

Distribution of the population according to mode of delivery.
		EMG(N = 170) NOT (%)	AMG(N = 170) NOT (%)	p
Road delivery	Vaginal	115(67.6)	79 (46.5)	< 0.001
	Instrumental	8 (4.7)	17 (10)	< 0.001
	caesarean section	47 (27.6)	74 (43.5)	< 0.001

Table 3

**Distribution of the population according to the indication for cesarean sections.**
	EMG(N = 170) NOT (%)	AMG(N = 170) NOT (%)	P
Start-up dystocia	7 (14.9)	9 (12.2)	0.66
Stagnation of expansion	7 (14.9)	4 (5.4)	0.077
Failure to Commit	9 (19.1)	6 (8.1)	0.072
Acute fetal distress	23 (48.9)	51 (68.9)	0.028
Intrauterine infection	1 (2.1)	4 (5.4)	0.64

Immediate maternal complications were reported in 36 cases and were more frequent in the AMG with a significant difference. The most frequent maternal complication was postpartum hemorrhage (PPH), which was more frequent in AMG with a significant difference between the two groups. The rate of late postpartum complications was similar in the two groups Table 4.

Table 4

Repartition of patients according to postpartum immediate complications.
	Expectant management N (%)	Active management N (%)	P
Maternal complications	5 (2.9)	31 (18.2)	< 0.001
Immediate postpartum hemorrhage	4 (2.4)	21 (12.4)	< 0.001
Cervical laceration	0 (0)	3 (1.8)	0.08
Perineal tears	2 (1.2)	10 (5.9)	0.019
Perineal hematoma	0 (0)	1 (0.6)	0.31
Other complications	0 (0)	1 (0.6)	0.31

The average hospital stay duration was 38 hours. This duration was higher in the AMG with a significant difference (p = 0.0001).

For neonatal outcomes, an Apgar score superior to 8 at first minute was reported in 93.5% of cases in the EMG group versus 84.7% of cases in the AMG, with significant difference between the two groups (p = 0.01). At the 5th min the Apgar score had improved for the entire population.

Medical resuscitation of the newborn was required in 10% of cases and admission in the neonatology department was necessary in 6% of cases. Those rates were significantly more frequent in the AMG (respectively p = 0.01 and p = 0.03). Similarly, neonatal complications dominated by acute respiratory distress were higher in the AMG. Table 5.

Table 5

Repartition of patients according to neonatal outcomes
	Rate (%)	EMG	AMG	p
Neonatal resuscitation	10.3	5.9	14.7	0.01
Admission in neonatology department	5.91	2.9	8.8	0.03
Neonatal complications	7	2.94	11.2	0.02
Respiratory acute syndrome	20/340	2.4	9.4	0.03

The average duration between intervention and vaginal delivery was 15 hours and 47 min for the EMG versus 8 hours and 26 min for the AMG (p = 0.001). The average duration of the latent phase was 20 hours and 38 min for the EMG and 13H and 19min for the AMG with a very significant difference (p < 0.001).

The average duration of the active phase was 5h and 14min for the EMG and 3h and 58min for the AMG with a significant difference (p < 0.001).

Concerning the parturients’ satisfaction, 82.4% of the parturients in EMG were satisfied withthe labor and delivery process versus 68.2% of the AMG with a significant difference between the two groups (p < 0.001). For immediate postpartum satisfaction, the majority of patients were very satisfied with no significant difference.

Table 6 summarizes the different outcomes for the two management groups.

Table 6

Comparison of outcomes in the EMG versus AMG
			EMG(N = 170) N (%)	AMG(N = 170) N (%)	p
Delivery route	Vaginal		115(67.6)	79 (46.5)	< 0.001
	Instrumental		8 (4.7)	17 (10)	< 0.001
	caesarean section		47 (27.6)	74 (43.5)	< 0.001
Immediate maternal complications	PPH		4 (2.4)	21 (12.4)	< 0.001
	Perineal tears		2 (1.2)	10 (5.9)	0.04
	Cervical laceration		0 (0)	3 (1.8)	0.08
	Perineal hematoma		0 (0)	1 (0.6)	0.31
Fetal complications	Apgar at 1 min	≤ 3	2 (1.2)	1 (0.6)	0.01
		Between 4 and 7	9 (5.3)	25 (14.7)	0.01
		≥ 8	159 (93.5)	144 (84.7)	0.01
	Neonatal resuscitation		10 (5.9)	25 (14.7)	0.01
	Neonatal transfer		5 (2.9)	15 (8.8)	0.03
Duration of labor	Duration between operation and vaginal delivery		15.79 (SD = 2.35)	8.44 (SD = 1.79)	0.0001
	Active phase duration		5.24 (SD = 0.68)	3.97 (SD = 0.59)	< 0.001
	Latency phase duration		20.63 (SD = 2.31)	13.32 (SD = 1.72)	< 0.001
Satisfaction	For the labor flow		140 (82.4)	116 (68.2)	< 0.001
Satisfaction	For immediate postpartum		163 (95.9)	155 (91.2)	> 0.05

The increase in the rate of caesarean section remains a major concern in Tunisia and even throughout the world. Prolonged latent phase of labor is a common indication for active management by amniotomy and oxytocin infusion in order to shorten the labor duration.

We present here the first Tunisian study comparing the results of expectant management with those of active management in the event of a prolonged latency phase.

Our study showed that expectant management reduced the rate of caesarean sections and could avoid both maternal and fetal complications and similar results were reported by several studies. In fact, Janne Rossen et al undertook a cohort study including 20227 women with singleton pregnancies ≥ 37 weeks, cephalic presentation, spontaneous labor and no history of caesarean section. Prior to the protocol's implementation, oxytocin was used if the progress of labor was perceived as slow. After implementation, oxytocin could only be started when there is an indication to hasten delivery. The overall rate of emergency caesarean sections decreased from 6.9–5.3% (p < 0.05) and the rate of emergency caesarean sections performed due to fetal distress was reduced from 3.2–2.0% (p = 0.01). (6)

In a study reported by Van Royen Laura at the medical-surgical and obstetrical center in Schiltigheim concerning the use of oxytocin in the latency phase, 193 patients were included. The authors concluded that the use of oxytocin significantly increased the rate of caesarean sections (p = 0.02) as well as the rate of instrumental delivery (p = 0.01) (7).

In addition, Piotr Baran et al reported that cesarean deliveries were noted in 16.97% of women in the AMG (16.97%) versus 8.85% in the control group (p < 0.001) (8).

Other studies have also shown an increase in the rate of caesareans for women in the latent phase who underwent labor management.(9–11). Jennifer L Ballit et al(9), evaluated all low-risk women with full-term pregnancies. The authors concluded that women admitted in the latent phase had more caesarean deliveries (14.2% vs 6.7%) and this can be explained by an active attitude using oxytocin and the use of amnitomy to accelerate labor.

In the same context, P Holmes et alconcluded that women presented with a cervical dilation less than 3 cm were more likely to undergo amnitomy and oxytocin infusion than those who present at more advanced labor, and that the cesarean section rate of these women is also significantly more increased (10.3% versus 4.2%)(10).

In our study, we noted PPH in 7.4% of cases. The literature reported similar rates varying from 5 to 10%.(12). Our results showed a low PPH rate for EMG. In fact, prolonged exposure to oxytocin during labor is associated with uterine atony and can increase risk of PPH due to desensitization of oxytocin receptors (13).

Gary Tranet al performed a retrospective study including 490 and concluded that an increased oxytocin recovery interval was associated with a decrease in blood loss during cesarean section among women with directed labor(13). Furthermore, A study carried out in the Port Royal maternity reported a significant association (p = 0.015) between compliance with the latent phase and the reduction in the rate of hemorrhage during delivery.(14).

Concerning the neonatal outcomes, we reported a lower rate of resuscitation in the delivery room and admission to neonatology in the EMG. Similarly, the study carried out by Pedro Hidalgo-Lopezosa et al showed significant difference in the pH of umbilical cord blood in primiparae, but no significant differences were found concerning either 5 minutes Apgar scores or neonatal resuscitation rates (15). The neonatal results of this study are comparable with those of previous studies, in which oxyctocin use was associated with lower umbilical cord pH values compared to unexposed mothers (16.17).

According to study carried out in the Port Royal maternity hospital (14), a significant association was found between expectant management and a lower rate of neonatal resuscitation (12.8% for the AMG and 5.3% for the EMG). A significant difference was reported for the 5 minutes Apgar score, the umbilical cord pH and the immediate admission to neonatal intensive care (p < 0.05).

However, the active management of prolonged latent phase allowed to shorten the duration of labor, saving occupation time in the delivery room at the expense of a longer hospital stay, with a very significant difference.

The study carried out by Zohar Nachumet al compared amniotomy, oxytocin or both for the acceleration of labor in the prolonged latency phase (5). The duration between the intervention and delivery was shorter in case of active management (7 hours versus 12.33 h in the control group, p < 0.001).

In addition, according to Heather C Brown et al, the duration between intervention and delivery was significantly longer for the control group compared to the active management group (p < 0.005) (18). In the study carried out by Sargunam et al in central Malaysia, the duration of the latent phase was 9.6 ± 10.2 for the AMG versus 29.6 ± 18.5 h for the EMG (p < 0.001) (19).

The EMG was associated with a higher satisfaction rate concerning the labor process (82.4% versus 68.2%). For immediate postpartum satisfaction, the majority of patients were very satisfied with no significant difference.

Some authors highlight specific indicators of satisfaction, such as women's active participation in the birth process, which increases childbirth satisfaction and positive long-term memory (20).

A systematic review showed that the factors involved in a woman's satisfaction were the consideration of her personal expectations, the support provided by health professionals, the quality of her relationship with them and her participation to decision (21). Indeed, the presence of pain does not necessarily reflect a negative childbirth experience, pain can coexist with satisfaction, joy and a feeling of power (22).

Furthermore, a Malaysian study on induction of labor demonstrated that maternal satisfaction is associated with a shorter interval between induction and delivery(23). A recent study also reported that women's perception of the healthcare quality, childbirth experience and feelings were associated with the latent phase duration (24).

However, Sargunamet al reported that, despite having a significantly shorter intervention until delivery, women who underwent expectant managemement showed better satisfaction with the delivery process and with the outcome of the baby but with no significant difference (19).

In our study, patients in the AMG were less satisfied with the childbirth experience despite the shorter labor duration. This can be explained by the high rate of emergency caesarean sections in this group, which causes a stressful situation for the patient and influences the quality of satisfaction.

Strengths and limitations of the study :

This study was a first prospective randomized study carried out in Tunisia with a size calculated from the data of a pre-survey, which allows high scientific level results.

In addition, sociodemographic characteristics, medical history and examination at admission were comparable between the two homogeneous and matched groups, allowing relevant statistical analyses. The sample size may also seem limited compared to the international literature data, but it is a large size compared to the Tunisian studies.

However, after randomization, the follow-up of the patients was ensured by several contributors (resident on call, midwife) which can be a source of bias, even if the investigating doctor was the same.

In our series, no patient benefited from epidural analgesia. Knowing the contribution of the epidural in obstetrical dynamics, the non-installation of the epidural in all patients could constitute a bias in our study.

Finally, the monocentric nature of the study can limit the possibility of generalizing the outcomes, which suggests prospectives for a multicenter study in order to conclude on definitive results.

The active attitude compared to the expectant attitude to manage the prolonged latent phase has shown several disadvantages. In fact, the active management is associated with more caesarean sections, more maternal complications, less safety for the newborn, longer hospital stay with less satisfaction rate.

According to this study, as well as to the results reported in the literature, expectant management in case the prolonged latency phase seems to be an effective alternative and we suggest its generalization.

ETHICS APPROVAL AND CONSENT TO PARTICIPATE:

The study was approved by the ethics committee of PROTECTION OF PEOPLE SOUTH, SFAX.

Approval was granted by the ethics committee of PROTECTION OF PEOPLE SOUTH, SFAX (ID: 0371/2021) (Approval date: 22.12.2021).

All methods were performed in accordance with the relevant guidelines and regulations set out by the Declaration of Helsinki.

An informed consent was obtained from all participants. Proof of consent to participate can be requested at any time.

The datasets generated and analyzed during the current study are not publicly available due to patient privacy but are available from the corresponding author.

CONSENT FOR PUBLICATION:

Not applicable.

AVAILABILITY OF DATA AND MATERIALS:

The datasets generated and analyzed during the current study are not publicly available due to patient privacy but are available from the corresponding author.

COMPETING INTERESTS:

The authors declare that they have no competing interests.

FUNDING:

No Funding was received.

AUTHORS’ CONTRIBUTIONS

OB, MD, contributed to the study design, data collection and data analysis.

OB, MD, FC, FK, contributed to manuscript writing and review.

KC, critically revised the manuscript.

All authors read and approved the final manuscript.

ACKNOWLEDGEMENTS:

Not applicable.

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Competing interest reported. The datasets generated and analyzed during the current study are not publicly available due to patient privacy but are available from the corresponding author.

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Active Management of Labor Versus Expectant Management of Primiparous Women With a Prolonged Latent Phase: A Randomized Trial

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Abstract

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INTRODUCTION

PATIENTS AND METHODS

a) Study design

b) Study population with selection criteria:

c) Data collection:

d) Management strategies

RESULTS

DISCUSSION

Strengths and limitations of the study :

CONCLUSION

Declarations

References

Additional Declarations

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