Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03435263 |
| Other study ID # |
ain shams university protocol |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
February 6, 2018 |
| Last updated |
February 9, 2018 |
| Start date |
February 1, 2018 |
| Est. completion date |
April 2019 |
Study information
| Verified date |
February 2018 |
| Source |
Ain Shams University |
| Contact |
ahmed mahmoud hussein, MD |
| Phone |
01205055563 |
| Email |
ahmedmhmoud82[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
According to high tendency for admission of cases of premature rupture of membranes (PROM)
for fear of maternal & fetal complications, we compare here between cases managed at hospital
with other managed at home for if there any difference between in maternal and neonatal
outcome.
Description:
Premature rupture of membranes (PROM) refers to rupture of fetal membranes prior to onset of
labor at term (> 37 weeks) (American college of obstetrician & gynecologist, 2007; Caughey et
al., 2008).
A premature rupture of membranes (PROM) is observed in 8% of all pregnancies after 37 wk of
gestational age,3% before and 5% after 37 weeks of gestation (Popowski et al., 2011;Keith,
2005) These membranes form an adjustable container for a developing and moving fetus, but it
has limited life time, existing only to the point of programmed rupture at term, which is a
normal event during the first stage of labor (Goldenberg and Rouse, 1998). As fetal membranes
act as a barrier to ascending infection, so once membranes rupture both mother & fetus are at
risk of infection and other complications (American college of obstetrician & gynecologist ,
2007).
The latent period of labor is the time from rupture of membranes to the onset of effective
uterine contractions, as this period tends to increase the risk of maternal and fetal
infection, maternal infection termed chorioamnionitis which occurs in 3-5% of cases of PROM.
While fetal infection occurs in about 15-20% in those with chorioamnionitis. Fetal infection
may occur as septicemia, pneumonia, UTI, local infection as omphalitis (infection of the
umbilical cord or conjunctivitis (Benedetto et al.,2004).
Other complications that may associated with PROM include umbilical cord prolapse in about
1.5% of cases of PROM. Placental abruption, caesarean delivery, postpartum hemorrhage and
postpartum infection (Modena et al.,2004).
Correct diagnosis of PROM has great importance because failure to diagnose can lead to
unwanted obstetric complications as chorioamnionitis, preterm birth. On the other hand over
diagnose can lead to unnecessary intervention like hospitalization. The approach to diagnose
rupture of membrane is clinical , with over 90% of cases being confirmed bases on the
presence of suspicious history or ultrasonographic finding followed be documentation of fluid
passing from the cervix (Hasan and Cevder et al., 2007).
The causes of PROM is not clearly understood, but the following risk factors that have been
shown to increase the chance of its happening. In many cases, however no risk factors can be
idintified.
1. Infection: UTI, STD, lower genital infection (ex: bacterial vaginosis).
2. Intrauterine infection.
3. Multiple previous pregnancies.
4. Cervical incompetency.
5. Hydramnios: too much AF.
6. Nutritional deficits.
7. Family history of PROM .(Ashley et al., 2003) . 8- Low socioeconomic status.
9-Multiple gestation: being pregnant with two or more fetuses at one time. 10- Previous
preterm delivery. (Andrew et al.,2000) 11- Having had episodes of bleeding anytime during
pregnancy. 12- Invasive procedure(ex: amniocentesis). 13- Being underweight. 14- Cigarette
smoking during pregnancy(Jones., 2004) 15- Illicit drug use during pregnancy. 16- Having had
PROM or preterm labor in previous pregnancy.(Parry., 2004) We observe in over 60% of the
cases spontaneous labor begins within 24 hours, in 95% within 72 hours. often labor is
induced after 24 hours because of the risk of maternal & neonatal is rising.
Majority of clinicians advise hospital care to allow monitoring and detection of problems.
But for low risk patients fulfilling strict criteria sometimes home management is possible.
The initial management of a woman presenting with suspecting PROM should focus on confirming
the diagnosis, validating the gestational age as maternal and fetal risks vary with the
gestational age at time of membranes rupture as proved by (Morales and Talley. ,1993 ) .
It is important to make a distinction between term PROM and preterm PROM (PPROM) which is
rupture of membranes before term (<37 weeks), as the conditions have different etiologies,
risks and recommended management plans (Jones., 2004)
