Premature Rupture of Fetal Membranes Clinical Trial
Official title:
Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM Study)
Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the
onset of regular uterine contractions.
PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to
80% of cases occurring at term. Approximately 90% of patients' experience PROM enter
spontaneous labor within 24 hours, but disagreement exists among health care providers on
the optimal management of women with PROM, particularly the need for and timing of
inductions.
Nipple stimulation is a non-medical natural method for induction of labor. Previous studies
demonstrated its effectiveness for initiating labor within 72 hours in women with favorable
cervices. The actual mechanism by which such a technique results in cervical ripening is not
well understood.
In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with
term PROM choosing expectant management.
The participants in the study will be randomized into two groups of expectant management
(patients desire an active approach will be excluded).
All eligible participants will be randomly allocated to either intervention or control
group. They will be followed from the time of presentation with rupture of membranes at the
ER and until the time of delivery. Prophylactic antibiotics will be administered after 18
hours from rupture of membranes as per departmental policy.
On admission, and after validating inclusion criteria, women will be offered to join the
study. For the intervention group women will be instructed to gently massage alternate
breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of
regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing
cream will be offered to facilitate the procedure according to individual preferences. In
the control group all participants will be asked to avoid any breast stimulation during the
study period.
For both groups maternal surveillance will include obstetrician assessment every 6 hours or
per maternal request if painful contractions. Every assessment will include documenting
maternal vital signs, sense of contraction, fetal cardiotocographic assessment and vaginal
examination if painful contractions. After delivery,all participants will be requested to
fill a satisfaction questionnaire.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02801227 -
Oxytocin vs. Prostaglandin for Induction of Labor in Primiparas With Prelabor Rupture of Membrane and Low Bishop
|
Phase 4 | |
| Completed |
NCT00940043 -
Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests
|
N/A | |
| Completed |
NCT01736852 -
Evaluation of CRB in PROM Patients
|
N/A | |
| Recruiting |
NCT05568745 -
Balloon + Oxytocin Versus Oral Misoprostol to Induce Labor in Case of PROM (RUBAPRO2)
|
Phase 4 | |
| Recruiting |
NCT03108404 -
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
|
N/A |