Active management of labor versus expectant management in first nulliparas with a prolonged latent phase: a randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202308714803965

Enrollment

340

Registered

2023-08-07

Start date

2021-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy and Childbirth other

Interventions

amniotomy and oxytocin infusion

expectative

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: ? Spontaneous entry into labor. ? A prolonged latent phase of labor (absence of cervical dilation beyond four centimeters after eight hours of regular uterine contractions (UC)). ? nulliparous (No previous pregnancy > 20 weeks). ? PFE between 2000 gram(g) and 4000g. ? The presence of CUs (at least 1 CU/30 min). ? Cervical dilation = 3 cm. ? Pocket of water (PDEA) intact. ? First trimester ultrasonography done. ? Pregnancy term (TG): = 37SA. ? A single, progressive pregnancy. ? Summit presentation. ? A good bony pelvis. ? Normal oscillating, normal reactive fetal heart rhythm recording (ERCF). ? Bishop score = 6.

Exclusion criteria

Exclusion criteria: ? Estimated fetal weight = 4000 g or = 2000 g. ? Induction of labor ? Contraindications to vaginal delivery. ? Scar womb (history of uterine surgery). ? Presence of a history of significant disease vs. direction of labor. ? Multiparity. ? TG < 37 SA. ? Bishop score < 6. ? Presentation other than summit. ? Pathological ERCF. ? Unexplained placenta previa or metrorrhagia.

Design outcomes

Primary

Measure	Time frame
The rate of cesarean section was 35.6% in the overall population, including 27.6% in the expectant management group versus 43.5% in the active management group; p<0.001. The rate of forceps delivery was 4.7% for the Expectative Management Group versus 10% for the Active Management Group; p<0.001 The rate of vaginal delivery without forceps was 67.6% for the Expectative Management Group versus 46.5% for the Active Management Group; p<0.001	—

Measure

Time frame

The rate of cesarean section was 35.6% in the overall population, including 27.6% in the expectant management group versus 43.5% in the active management group; p<0.001. The rate of forceps delivery was 4.7% for the Expectative Management Group versus 10% for the Active Management Group; p<0.001 The rate of vaginal delivery without forceps was 67.6% for the Expectative Management Group versus 46.5% for the Active Management Group; p<0.001

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Secondary

Measure	Time frame
For secondary endpoints, immediate maternal complications were noted in 36 cases. They were more common in the Active Management Group with significant difference. The most common maternal complication was postpartum hemorrhage (PPH) and it was most common in the Active Management Group with significant difference between the two groups. The rate of late postpartum complications was similar in both groups. And the mean length of hospitalization was 38 hours, it was greater in the Active Management Group with a significant difference. Neonatally, for the apgar score at the first minute, 93.5% of neonates in the expectation management group were well adapted to extrauterine life with apgar score > 8 versus 84.7 in the active management group, with a significant difference between the two groups. By the 5th minute, the apgar score had improved for the entire population. Resuscitation procedures were required in 10% of cases and hospitalization in the neonatology department in 6% of cases. They were significantly more frequent in the Active Management Group. Similarly, complications dominated by acute respiratory distress were higher for this group. For the duration of labor, the average time between surgery and vaginal delivery was 15 h and 47 min for the expectation group and 8 h and 26 min for the active group. With significant difference, (p=0.001). The mean duration of the latency phase was 20 h and 38 min for the Expectative Management Group and 13 Het 19 min for the Active Management Group with a very significant difference (p<0.001).	—

Measure

Time frame

For secondary endpoints, immediate maternal complications were noted in 36 cases. They were more common in the Active Management Group with significant difference. The most common maternal complication was postpartum hemorrhage (PPH) and it was most common in the Active Management Group with significant difference between the two groups. The rate of late postpartum complications was similar in both groups. And the mean length of hospitalization was 38 hours, it was greater in the Active Management Group with a significant difference. Neonatally, for the apgar score at the first minute, 93.5% of neonates in the expectation management group were well adapted to extrauterine life with apgar score > 8 versus 84.7 in the active management group, with a significant difference between the two groups. By the 5th minute, the apgar score had improved for the entire population. Resuscitation procedures were required in 10% of cases and hospitalization in the neonatology department in 6% of cases. They were significantly more frequent in the Active Management Group. Similarly, complications dominated by acute respiratory distress were higher for this group. For the duration of labor, the average time between surgery and vaginal delivery was 15 h and 47 min for the expectation group and 8 h and 26 min for the active group. With significant difference, (p=0.001). The mean duration of the latency phase was 20 h and 38 min for the Expectative Management Group and 13 Het 19 min for the Active Management Group with a very significant difference (p<0.001).

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Countries

Tunisia

Contacts

Public Contactoussema bardaa

resident

bardaaoussema@gmail.fr+21652430325

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026