An observational study in Management of Women With PROM at Term, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Ain Shams University · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Fetal Membranes, Premature Rupture · Egypt.
Among the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt, this one is one of 6 that started in 2018, is one of 8 observational ones, and was the 4th registered.
100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.
Browse Fetal Membranes, Premature Rupture studies →2 of the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt are open now. Recruiting first, the newest first:
Sohag University · Sites in Egypt
Ages 20–40 · Women only · Healthy volunteers
Ain Shams Maternity Hospital · Sites in Egypt
Ages 18–40 · Women only
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 12 Fetal Membranes, Premature Rupture studies recruiting now, 7 (58%) set no upper age limit and 5 (42%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 20 Years to 35 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 6 started in 2018.
This study's planned enrollment of 72 is below the median of 122 across 36 observational studies indexed under Fetal Membranes, Premature Rupture.
Median enrollment 120 across the 4 interventional studies, 86 across the 8 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 12 has an industry lead sponsor. The 8 most frequent:
Ain Shams University is the lead sponsor of 1,954 studies on the registry; 430 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ain Shams University has 3 studies filed under Fetal Membranes, Premature Rupture — fewer than ten, so there is no comparison to draw.
1 of the studies in Fetal Membranes, Premature Rupture with a site in Egypt that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07841587Ain Shams Maternity HospitalPrediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes | 2027-03 |
Add it to your calendar (.ics) → With an account.
Among the 12 studies in Fetal Membranes, Premature Rupture with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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)
This study will be carried out on 72 pregnant women recruited from Obstetric Department of Ain Shams University Maternity Hospital presented with PROM after 37 weeks of gestation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Maternal age \< 20 or > 35 years old. Multiple pregnancy. Rupture of membranes before 37 weeks of gestation or postdate. Suspected IUGR. SuspectedFetal weight > 4 kg (suspected by clinical examination or ultrasound).
Congenital fetal anomalies. Malpresentation or malposition. Placental abnormalities. High risk pregnancy as hypertension, DM and pre-eclampsia . Evidence suggesting onset of spontaneous delivery (e.g.: vaginal bleeding or uterine contractions).
Previous cesarean section or other uterine surgery. Presence of signs of chorioamnionitis. Presence of signs of fetal distress. Meconium stained liquor. Mental condition rendering
Women presented with premature rupture of membranes will be admitted at hospital.
home management
Other: home management
pregnant women presented with PROM will be randomized into 2 groups group a will be discharged home after initial assessment and group B will be admitted to hospital as usual
latency period.
time form rupture of membranes till starting labor
Time frame: up to 24 hours
NICU admission
neonatal ICU admission
Time frame: first 24 hours after delivery
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Feb 2019, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fetal Membranes, Premature Rupture →