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Amniotomy during the active phase defined by the new WHO definition versus expectant on the duration of labor: a randomized controlled trial.

Amniotomy during the active phase defined by the new WHO definition versus expectant on the duration of labor: a randomized controlled trial.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200522001
Enrollment
246
Registered
2020-05-22
Start date
2020-06-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Amniotomy during delivery at gestational age between 37-41 weeks amniotomy, duration of labour, expectant management, maternal outcome, neonatal outcome

Interventions

Amniotomy, also known as artificial rupture of membranes (AROM) and by the lay description breaking the water is the intentional rupture of the amniotic sac by an obstetrical provider. This procedure
Amniotomy,no-amniotomy

Sponsors

No
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 49 Years

Inclusion criteria

Inclusion criteria: i) a woman with a term singleton nulliparous, multiparous pregnancy gestational age between 37-41 weeks; ii) a fetal cephalic presentation with spontaneous labor; iii) cervical dilatation of 5 cm.; iv) painful uterine contraction every five minutes for at least one hour; v) the fetal head is fixed in the pelvis, and vi) no history of amniotic membrane rupture.

Exclusion criteria

Exclusion criteria: medical illness, an obstetrical complication, a contraindication for amniotomy, a uterine scar, fetal anomaly, and a non-reassuring fetus.

Design outcomes

Primary

MeasureTime frame
duration of labor after amiotomy or no-amniotomy time from amniotomy/no-amnioytomy to fully dilatation of cervix

Secondary

MeasureTime frame
second stage of labor, the cesarean section rate, oxytocin use, analgesic use. Apgar score at 1 and 5 minute, neonatal intensive care unit (NICU) admission after amiotomy or no-amniotomy after fully dilatation of cervix

Countries

Thailand

Contacts

Public ContactSirisopa Kamkreua

lamphun Hospital, 177 jamthevee Road, Lamphun, Thailand 51000

sirisopa2511@gmail.com053569100

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026